Teriparatide In Patients Research Articles

Comparative effectiveness and cardiovascular safety of romosozumab versus teriparatide in patients with osteoporosis: a population-based cohort study.

This study aimed to determine the preventive effects of romosozumab versus teriparatide on fractures and the risk of cardiovascular events in patients initiating these drugs. We conducted an active comparator, a new user cohort design, with confounding controlled by inverse probability of treatment weighting using a Japanese administrative claims database (March 2019 to October 2022). This cohort study included 49,104 patients aged 50years or older who initiated romosozumab (n = 16,125) or teriparatide (n = 32,979) for osteoporosis. The study exposure was the initiation of romosozumab or teriparatide. Effectiveness outcomes were nonvertebral fracture and hip fracture. The safety outcome was major adverse cardiac events (MACE). Follow-up period was 365days. The weighted incidence rate difference (IRD) for nonvertebral fracture between romosozumab versus teriparatide was -0.08 (95% confidence interval [CI], -0.34 to 0.17) events per 100 person-years (weighted hazard ratio [HR], 0.95 [95% CI, 0.81 to 1.12]); weighted IRD for hip fracture was 0.00 (95% CI, -0.16 to 0.16) events per 100 person-years (weighted HR, 0.99 [95% CI, 0.76 to 1.29]); and weighted IRD for MACE was -0.06 (95% CI, -0.20 to 0.09) events per 100 person-years (weighted HR, 0.90 [95% CI, 0.68 to 1.19]). In patients with osteoporosis, there was no significant difference in the prevention of nonvertebral fracture and hip fracture between romosozumab and teriparatide. In addition, the risk of MACE was comparable between the two drugs.

THU434 A Case Of An Atypical Femur Fracture Managed Medically With Teriparatide

Abstract Disclosure: S.V. Rupani: None. A. Kotwal: None. L. Graeff-Armas: None. Atypical femur fractures (AFFs) are atraumatic or low-trauma femur fractures located in the sub-trochanteric region or femoral shaft. AFFs represent around 0.5% of all femur fractures. The increased use of bisphosphonates has led to a rise in the incidence of AFFs as it has emerged as a potential complication. While the mechanism of bisphosphonate-related AFFs has yet to be elucidated, one proposed mechanism is that bisphosphonates can cause over-suppression of bone turnover. If over-suppression is a contributing factor, then hypothetically, anabolic therapy can help heal existing fractures and prevent impending fractures by reversing over-suppression. Numerous animal models have demonstrated that parathyroid hormone and teriparatide enhance fracture healing. However, clinical trials and meta-analyses on the effects of teriparatide in fracture healing have been equivocal. There have been both retrospective and prospective studies, along with anecdotal reports demonstrating the benefits of teriparatide in healing in AFFs. However, there have been no randomized controlled trials assessing the efficacy of teriparatide in AFFs. Based on this limited evidence, the American Society for Bone and Mineral Research recommends considering teriparatide in patients who have failed conservative therapy. We present a case of an incomplete AFF in the setting of short-term bisphosphonate use that was managed with teriparatide in addition to conservative measures. Our patient presented with a complete right AFF treated surgically and an incomplete left AFF that we managed medically with teriparatide. Repeat left femur imaging six months after starting teriparatide therapy showed interval callus formation consistent with a healed fracture. Right femur imaging also showed a healing proximal femoral shaft fracture status post intramedullary fixation. She completed twenty-five months of teriparatide therapy and did not sustain any interval fractures. Repeat imaging one year after completion of teriparatide therapy continued to show a stable healed left AFF, along with a healed right AFF. She is currently more than two years post-completion of teriparatide and has remained fracture free. This case highlights the role that teriparatide may have as an option for medical management in incomplete AFFs and to accelerate healing in complete AFFs that have been managed surgically. Furthermore, with therapeutic options for osteoporosis management limited in the post-AFF setting, teriparatide helps increase bone mineral density and reduce future fracture risk. Randomized controlled trials are needed to draw definite conclusions on the efficacy of teriparatide in managing AFFs. However, this is difficult given the rare occurrence of AFFs. Therefore, case reports like ours offer insight into when teriparatide may be helpful in managing AFFs. Presentation: Thursday, June 15, 2023

An effect comparison of alendronate and teriparatide in patients with glucocorticoid-induced osteoporosis: A protocol for systematic review and meta-analysis

Glucocorticoid-induced osteoporosis is the most common secondary cause of osteoporosis and the resulting fractures cause significant morbidity. Oral bisphosphonates are currently regarded as first line options on the grounds of their low cost. However, teriparatide has been shown to be superior in its effects on bone mineral density and vertebral fracture risk in glucocorticoid-treated individuals with osteoporosis. We conducted a protocol for systematic review and meta-analysis to assess the effectiveness of alendronate and teriparatide in patients with glucocorticoid-induced osteoporosis. The study protocol has been registered on international prospective register of systematic review (PROSPERO registration number: CRD42022371561). The procedure of this protocol will be conducted according to the Preferred Reporting Item for Systematic Review and Meta-analysis Protocols guidance. PubMed, EMBASE, MEDLINE, the Cochrane Library, Chinese National Knowledge Infrastructure, Chinese Biomedical Literature Database, Wanfang Database, ClinicalTrials.gov trials registry, and Chinese Clinical Trial Registry will be searched from January 1980 to November 2022. Two authors will assess methodological quality of included studies separately by the Cochrane collaboration's risk of bias tool. We will apply RevMan 5.4 software for statistical analysis. This study will provide a high-quality comprehensive evaluation of the efficacy and safety of alendronate and teriparatide for treating patients with glucocorticoid-induced osteoporosis. The conclusion of our systematic review will provide evidence to judge whether teriparatide is an effective intervention for patients with glucocorticoid-induced osteoporosis.

Effect of adjuvant therapy with teriparatide in patients with thoracolumbar osteoporotic vertebral fractures who underwent vertebroplasty with posterior spinal fusion

Teriparatide (TPTD) administration has a potent osteogenic action and promotes the healing of osteoporotic vertebral fractures (OVFs). We aimed to investigate the outcomes of vertebroplasty with posterior spinal fusion (VP + PSF) and determine the impact of perioperative TPTD administration. We included 73 patients (18 male and 55 female patients; mean age: 78 years) with thoracolumbar OVFs who underwent VP + PSF and were followed-up for at least 2 years. Twenty-three patients who received TPTD perioperatively for > 3 months were included in the TPTD group, and the remaining 50 patients were included in the non-TPTD group. Radiographic findings regarding sagittal alignment and clinical outcomes in both groups were compared. The mean duration of TPTD administration was 17.5 ± 5.0 months (range 4–24 months). The mean loss of correction of local kyphosis angle in the TPTD group (4.0°) was lesser than that in the non-TPTD group (7.5°; p < 0.05); however, no significant differences were observed between the groups regarding global sagittal alignment, the occurrence of subsequent vertebral fractures, pedicle screw loosening and treatment-efficacy rates of clinical outcomes. Local kyphosis correction in patients who underwent VP + PSF for OVFs could be maintained through perioperative TPTD administration; however, TPTD administration had little effect on clinical outcomes.

Teriparatide in individuals with a prior history of radiation therapy-a case series.

Teriparatide is a highly effective anabolic therapy for use in patients with osteoporosis at elevated fracture risk but carries a warning about an increased risk of osteosarcoma based on findings from pre-approval animal studies. Since approval, follow-up of individuals treated with teriparatide has not shown an increased risk of osteosarcoma, but it is still recommended to avoid teriparatide in patients with risk factors for osteosarcoma. One such risk factor is radiotherapy; deciding whether to use teriparatide therapy in patients at high risk of fracture but with a history of radiotherapy is therefore a frequent clinical problem. We sought to identify whether clinicians are using teriparatide in patients with a history of radiotherapy despite the warning and to explore the rationale for this choice. Herein, we describe six cases where the likelihood of fracture, osteosarcoma, and the benefits of teriparatide treatment are assessed to determine the appropriateness of prescribing teriparatide in the setting of prior or concurrent radiotherapy. All six patients had severe osteoporosis with limited treatment options. For those who completed 2 years of teriparatide, no further fractures during the follow-up period have occurred, and improvements in bone density (as measured by dual-energy X-ray absorptiometry) were observed. Despite radiotherapy being a relative contraindication to teriparatide use, there may be a role for teriparatide in select cases where osteoporosis is complex and severe and where other treatment options are not suitable or have been exhausted. The risks vs. benefits of prescribing teriparatide in this population should always be carefully considered, and both the patient and treating oncologist should be educated on the potential risk of osteosarcoma development when teriparatide is continued during radiotherapy.

Efficacy of once-weekly teriparatide in patients with glucocorticoid-induced osteoporosis: the TOWER-GO study.

Bisphosphonates are the standard treatment for glucocorticoid-induced osteoporosis (GIOP) with teriparatide being another option. While daily teriparatide has been shown to be effective in increasing bone mineral density (BMD), the efficacy of once-weekly teriparatide (56.5µg) has not yet been evaluated. The TOWER-GO study, a 72-week, multicenter, open-label, randomized controlled trial, was conducted in patients with GIOP to compare the effects of once-weekly teriparatide and once-weekly alendronate 35mg on BMD. Patients (N = 180) with GIOP for whom drug treatment was indicated according to the 2004 guidelines in Japan were randomized to receive once-weekly teriparatide (n = 89) or once-weekly alendronate (n = 91). The primary endpoint was the non-inferiority of percentage change in lumbar spine BMD at final follow-up. The secondary endpoints were the percentage change in BMD from baseline, incidence of bone fractures, and changes in bone turnover markers. While the non-inferiority of teriparatide to alendronate was not confirmed, BMD increased significantly from baseline with teriparatide and alendronate by 5.09% and 4.04%, respectively (both p < 0.05), at 72weeks. The incidence of vertebral and non-vertebral fractures was similar in both groups. Bone formation markers increased in the teriparatide group and decreased in the alendronate group. The non-inferiority of once-weekly teriparatide versus once-weekly alendronate in BMD change at 72weeks was not shown, but the increase in bone formation markers over time and the increase of BMD in GIOP patients treated with once-weekly teriparatide were confirmed.

Therapeutic effect and medication adherence of daily teriparatide in patients with type II diabetes mellitus-related osteoporosis

Therapeutic effect and medication adherence of daily teriparatide in patients with type II diabetes mellitus-related osteoporosis

Влияние на бюджет системы здравоохранения применения препарата терипаратид при лечении пациентов с тяжелым остеопорозом в сравнении с антирезорбитивными препарами

Objective: budget impact assessment on the healthcare system use of teriparatide in the treatment of severe osteoporosis in comparison with antiresorptive drugs. Material and methods. Study Design – retrospective literature analysis. Methods of pharmacoeconomic analysis: cost analysis, the “budget impact” analysis, sensitivity analysis. In the study, patients were considered as a target group for prescribing the drug teriparatide or antiresorptive therapy with severe postmenopausal osteoporosis with the presumed development of two compression fractures requiring surgical reconstruction. Results. The use of teriparatide in patients with two low-traumatic vertebral fractures will require a cost 1.4% less than treatment with zoledronic acid and 33.07% less than the treatment with alendronic acid and 13.6% less in comparison with the use of denosumab. At a weighted average frequency of 3 clinically significant fractures per year, the use of teriparatide will require 15.0%, 42.9% and 24.7% less cost, respectively. For a group of 1000 patients with 2 fractures per year, the savings over 4 years will amount to 13.7 million rubles, 483.0 million rubles, respectively and 154.1 million rubles. With a more severe course, expressed in an increase in the number of fractures to 3 per year, budget savings over 4 years per 1000 patients will amount to 219.0 million rubles, 930.9 million rubles and 406.0 million rubles, respectively. A sensitivity analysis showed that on a 4-year horizon, the use of teriparatide remains economically feasible with a decrease in the frequency of fractures to 1.95 per year compared to zoledronic acid, to 1.4 per year compared to denosumab and to 0.95 per year compared alendronic acid. Conclusion. Teriparatide is more cost effective than antiresorptive drugs for severe osteoporosis, when an average of 2 clinically significant vertebral fractures per year can be expected in untreated patients requiring surgical reconstruction. In this way, the appointment of teriparatide as the first line of therapy for osteoporosis in patients at high risk of fractures, having more than one clinically significant fracture of the vertebral body in a history is justified from a pharmacoeconomic point of view.

Abaloparatide in patients with mild or moderate renal impairment: results from the ACTIVE phase 3 trial

Objective: To evaluate, post hoc, the efficacy and safety of abaloparatide by degree of renal impairment.Methods: ACTIVE was a phase 3, 18-month, randomized, double-blind, active-comparator, placebo-controlled study of postmenopausal women with osteoporosis who received subcutaneous abaloparatide 80 µg, placebo, or open-label teriparatide 20 µg daily. Patients with serum creatinine >2.0 mg/dL or 1.5–2.0 mg/dL with an estimated glomerular filtration rate (eGFR) <37 mL/min, calculated by Cockcroft-Gault formula, were excluded.Results: At baseline, 660 patients had eGFR ≥90 mL/min, 1276 had 60 to ˂90 mL/min, and 527 had <60 mL/min. Older age and lower T-scores were associated with greater renal impairment. Among renal-function subgroups, there were no meaningful changes in bone mineral density, fracture risk reduction, or overall incidence of treatment-emergent adverse events in the active-treatment arms. Anemia, nausea, hypercalcemia, and upper-respiratory-tract infection tended to be more frequent with increasing renal impairment. Hypercalcemia measured by albumin-adjusted serum calcium occurred significantly less frequently with abaloparatide than teriparatide in patients with eGFR <60 mL/min (3.6% versus 10.9%; p = .008) and in the overall ACTIVE safety population (3.4% versus 6.4%; p = .006). Computed tomography scans in 376 patients revealed no evidence of increased renal calcification.Conclusion: Increased exposure to abaloparatide and teriparatide in patients with renal impairment led to no meaningful differences in efficacy or safety. These results support the use of abaloparatide without dosage adjustment in patients with renal impairment, provided those with severe renal impairments are monitored for adverse events.

A multicenter, randomized, rater-blinded, parallel-group, phase 3 study to compare the efficacy, safety, and immunogenicity of biosimilar RGB-10 and reference once-daily teriparatide in patients with osteoporosis

SummaryThe efficacy and safety of RGB-10 and reference teriparatide were evaluated in a randomized 52-week study in 250 patients with osteoporosis at high risk of fracture. RGB-10 was equivalent to reference teriparatide in efficacy and had a comparable safety profile.IntroductionRGB-10 is the first biosimilar teriparatide authorized in the European Union. This multicenter, randomized, rater-blinded, parallel-group phase 3 study evaluated equivalence in efficacy and compared safety between RGB-10 and reference teriparatide in patients with osteoporosis at high risk of fracture for registration in Japan.MethodsAmbulatory postmenopausal women and men (≥ 55 years of age) with osteoporosis at high risk of fracture were randomized 1:1 to receive either RGB-10 or reference teriparatide 20 μg once daily via subcutaneous self-injection for 52 weeks. The primary efficacy endpoint was the percent change from baseline to 52 weeks in lumbar spine (L2–L4) bone mineral density (BMD). Safety outcomes and immunogenicity were also assessed.ResultsIn total, 250 patients (125 in each group) were randomized. The percent change from baseline to 52 weeks in lumbar spine (L2–L4) BMD (mean ± standard deviation) was 8.94% ± 6.19% in the RGB-10 group and 9.65% ± 6.22% in the reference teriparatide group. The estimated between-group difference (95% confidence interval) was − 0.65% (− 2.17% to − 0.87%) within the pre-specified equivalence margin (± 2.8%), which indicates equivalence in efficacy between the two groups. Changes in BMD at lumbar spine (L1–L4), femoral neck, and total hip and serum procollagen type I amino-terminal propeptide were also similar between the groups. Safety profiles, including immunogenicity, were comparable.ConclusionsThe therapeutic equivalence of RGB-10 to reference teriparatide was demonstrated. RGB-10 had comparable safety profile to that of reference teriparatide.

First initiation one month has been important to the medication adherence of daily teriparatide in patients of osteoporosis

First initiation one month has been important to the medication adherence of daily teriparatide in patients of osteoporosis

Wednesday, September 26, 2018 1:00 PM – 2:00 PM Spinal Trauma: 55. Aggravation of spinal cord compromise following new osteoporotic vertebral compression fracture prevented by teriparatide in patients with surgical contraindications

BACKGROUND CONTEXT Osteoporotic fractures occur frequently in people over 50 years of age, with prevalence of 40%–50% in women and 13%–22% in men, among which osteoporotic vertebral compression fracture (OVCF) is the most common type. Although a large percentage of OVCFs are stable, the unstable OVCFs are not rare. Compared with the stable OVCFs, the unstable OVCFs could associate with neurological deficits and lead to higher morbidity and mortality. The unstable OVCFs usually are not candidates for cement-augmentation treatment, and the neurological deficits may aggravate after the traditional nonoperative treatment. Open surgery, which decompresses the spinal cord and stabilizes the fractured vertebrae by implanted instruments, is a potential option for the unstable OVCF to prevent further spinal cord compromise. However, if they have severe bone fragility or comorbid medical problems, decompression and instrument implantation surgeries are contraindicated. Teriparatide (Forteo, Eli Lilly and Co. Indianapolis, IN, USA) is the first bone anabolic drug approved by the US Food and Drug Administration for reducing the incidence of osteoporotic fracture. Recently, teriparatide has been shown to produce significant improvement of bone strength by improving bone turnover and bone mineral density (BMD). Lately, Park et al have applied teriparatide in treatment of the stable OVCF and found that short-term teriparatide treatment could decrease the progression of the fractured vertebral body collapse. In the present study, patients with neurological deficits following new unstable OVCF and with surgical contraindications were randomized into two groups receiving teriparatide/alendronate. We evaluated whether teriparatide can prevent the further fractured vertebral body collapse and prevent aggravation of spinal cord compromise in unstable OVCF. We hypothesized that conservative treatment with teriparatide would improve bone turnover parameters and BMD to strengthen the fractured vertebrae to be stabilized, as well as prevent aggravation of the spinal cord compromise. PURPOSE This study compared the preventive effects of teriparatide and alendronate on aggravation of spinal cord compromise following new unstable -OVCF- in patients with surgical contraindications. STUDY DESIGN/SETTING This was a 12-month, randomized, open-label study of teriparatide versus alendronate in 49 patients with new unstable OVCF and surgical contraindications. Neurological function was evaluated using modified Japanese Orthopedic Association (mJOA) score (11-point scale, the maximum score of 11 implies normalcy). Visual analog scale (VAS) scores, kyphotic angles, anterior-border heights and diameters of the spinal canal of the fractured vertebrae, any incident of new OVCFs (onset of OVCF during follow-up), spine bone mineral density (BMD), and serum markers of bone resorption and bone formation were also examined at baseline and 1, 3, 6, and 12 months after initiation of the medication regimen. PATIENT SAMPLE This was a 12-month, open-label, randomized controlled trial, conducted at our center, which compared the effects of teriparatide (Forteo, Eli Lilly, Indianapolis, IN, USA) and alendronate (Fosamax, Merck & Co., Kenilworth, NJ, USA) on patients with neurological deficits following new unstable OVCF and with surgical contraindications. From September 2012 to August 2014, we prospectively selected inpatients and outpatients who presented to our center with osteoporosis and new OVCF between T1 and L1. Inclusion criteria were female sex, age 60-80 years, new fracture within 3 weeks, single-level fracture without burst component, associated neurological deficit, L2–L4 BMD Tscore ≤−2.5, severe bone fragility (low BMD, ie, OUTCOME MEASURES Statistical analysis was performed using SPSS Statistics for Windows, Version 17.0 (SPSS Inc., Chicago, IL, USA). Results are presented as mean ± standard deviation. Depending on the normality of the data, the independent sample t test and Mann-Whitney U test were used to compare parameters between the two groups, while a paired t test was performed to analyze intra-group differences. Significance was accepted for a P value of RESULTS At 12 months, mean mJOA score had improved in the teriparatide group and decreased in the alendronate group. Mean concentrations of bone formation and bone resorption biomarkers, mean spine BMD, and mean anterior-border height and spinal canal diameter of the fractured vertebrae were significantly greater in the teriparatide group than in the alendronate group. Mean VAS score, mean kyphotic angle of the fractured vertebrae, and incidence of new OVCFs were significantly smaller in the teriparatide group than in the alendronate group. CONCLUSIONS In patients with neurological deficits following new unstable OVCF and with surgical contraindications, teriparatide was better than alendronate at improving the BMD and the bone turnover parameters, as well as preventing aggravation of spinal cord compromise. FDA DEVICE/DRUG STATUS This abstract does not discuss or include any applicable devices or drugs.

Effects of Teriparatide in Patients with Osteoporosis in Clinical Practice: 42-Month Results During and After Discontinuation of Treatment from the European Extended Forsteo\xae Observational Study (ExFOS)

This study aimed to describe clinical outcomes in patients prescribed teriparatide and followed up for 18 months after stopping the drug in real-life conditions. The Extended Forsteo® Observational Study analysed incident clinical fractures in 6-month intervals using logistic regression with repeated measures. Changes in back pain (visual analogue scale) and health-related quality of life (HRQoL; EQ-5D questionnaire) were analysed using mixed models for repeated measures. Patients were analysed if they had a post-baseline visit, regardless of whether and for how long they took teriparatide. Of 1531 patients analysed (90.7% female, mean age: 70.3 years), 76 (5.0%) never took teriparatide. Median treatment duration was 23.6 months. The adjusted odds of clinical fracture decreased by 47% in the > 12- to 18-month treatment period (p = 0.013) compared with the first 6-month period, with no statistically significant reduction in the > 18- to 24-month interval. The clinical fracture rate remained stable during the 18 months’ post-teriparatide, when approximately 98% of patients took osteoporosis medication (51% bisphosphonates). Clinical vertebral fractures were reduced at every time period compared with the first 6 months. Adjusted mean back pain scores decreased and EQ-5D scores increased significantly at each post-baseline observation. In a real-life clinical setting, the risk of clinical fractures declined during 24 months of teriparatide treatment. This reduction was maintained 18 months after stopping teriparatide. In parallel, patients reported significant improvements in back pain and HRQoL. The results should be interpreted in the context of the non-controlled design of this observational study.

Abaloparatide: Review of a Next-Generation Parathyroid Hormone Agonist.

To review the efficacy, safety, and economics of abaloparatide in the treatment of postmenopausal osteoporosis. PubMed (1966 to October 2017), Clinicaltrials.gov (October 2017), and Scopus (1970 to October 2017) were searched using abaloparatide, Tymlos, BA058, PTHrP 1-34 analog, and parathyroid hormone-related peptide 1-34 analog. Human studies published in peer-reviewed publications in English were the primary sources for efficacy, safety, and economic data. In the 2 randomized, published clinical studies of 24 weeks and 18 months duration, bone mineral density changes were higher for abaloparatide (lumbar spine, 6.7%-11.2%; femoral head, 3.1%-3.2%; total hip, 2.6%-4.2%) compared with placebo (lumbar spine, 0.6%-1.6%; femoral head, -0.4% to 0.8%; total hip, -0.1% to 0.4%; P < 0.05) and compared with teriparatide in the 24-week study (total hip 2.6% vs +0.5%, P < 0.05). New vertebral and nonvertebral fractures occurred in 0.6% and 2.7% of patients on abaloparatide compared with 4.2% and 4.7% on placebo in the 18-month study ( P < 0.05). Abaloparatide appears to have a somewhat higher risk for adverse effects, discontinuation as a result of adverse effects, and serious or severe adverse effects than teriparatide, but teriparatide has a higher risk for hypercalcemia. Pharmacoeconomic modeling appears to favor abaloparatide if differences in efficacy and cost are maintained. Abaloparatide, which has less effect on osteoclasts, is an alternative to teriparatide in patients with postmenopausal osteoporosis who are at high risk for fractures or who have failed antiresorptive therapy based on initial clinical studies and economic modeling.

Short-term daily teriparatide in patients with rheumatoid arthritis

Objective: The aim of this study was to compare the efficacy of six-month teriparatide treatment followed by six-month bisphosphonate therapy with 12-month bisphosphonate monotherapy in Japanese rheumatoid arthritis (RA) patients who had not been previously treated for osteoporosis.Methods: A total of 34 RA patients with osteoporosis were enrolled. Thirteen patients received six-month teriparatide prior to six-month minodronate therapy (PTH group), and 21 patients received 12-month minodronate therapy (BP group). Bone mineral density (BMD), and bone turnover markers were measured prior to and 6 and 12 months after the initiation of treatment.Results: Bone mineral density of the spine was significantly increased after 12 months of treatment in both groups. In the PTH group, the mean percent change of BMD of the spine was significantly higher at 12 months after the initiation of treatment, as compared to the BP group (PTH group: 9.9 ± 1.5%, BP group: 5.5 ± 0.7%). Femoral neck BMD was significantly increased only in the PTH group after 12 months.Conclusion: Therapy involving six-month teriparatide followed by six-month minodronate therapy increased spine BMD to a greater degree than 12-month minodronate monotherapy. The strategy of short-term administration of teriparatide for RA patients with osteoporosis might be useful when additional bisphosphonate therapy is considered.

Assessment of the effects of switching oral bisphosphonates to denosumab or daily teriparatide in patients with rheumatoid arthritis.

The aim of this observational, non-randomized study was to clarify the unknown effects of switching oral bisphosphonates (BPs) to denosumab (DMAb) or daily teriparatide (TPTD) in patients with rheumatoid arthritis (RA). The characteristics of the 194 female patients included in the study were 183 postmenopausal, age 65.9years, lumbar spine (LS) T score -1.8, femoral neck (FN) T score -2.3, dose and rate of taking oral prednisolone (3.6mg/day) 75.8%, and prior BP treatment duration 40.0months. The patients were allocated to (1) the BP-continue group (n=80), (2) the switch-to-DMAb group (n=74), or (3) the switch-to-TPTD group (n=40). After 18months, the increase in bone mineral density (BMD) was significantly greater in the switch-to-DMAb group than in the BP-continue group (LS 5.2 vs 2.3%, P<0.01; FN 3.8 vs 0.0%, P<0.01) and in the switch-to-TPTD group than in the BP-continue group (LS 9.0 vs 2.3%, P<0.001; FN 4.9 vs 0.0%, P<0.01). Moreover, the switch-to-TPTD group showed a higher LS BMD (P<0.05) and trabecular bone score (TBS) (2.1 vs -0.7%; P<0.05) increase than the switch-to-DMAb group. Clinical fracture incidence during this period was 8.8% in the BP-continue group, 4.1% in the switch-to-DMAb group, and 2.5% in the switch-to-TPTD group. Both the switch-to-DMAb group and the switch-to-TPTD group showed significant increases in LS and FN BMD, and the switch-to-TPTD group showed a higher increase in TBS compared to the BP-continue group at 18months. Switching BPs to DMAb or TPTD in female RA may provide some useful osteoporosis treatment options.

Bone Mineral Density Response from Teriparatide in Patients with Osteoporosis.

A review of data from large clinical trials reported more than 90% of subjects significantly improved their bone mineral density (BMD) at the lumbar spine (LS) with teriparatide (TPTD) (bone 39:1268-1275, 1). However, our clinical experience suggests that many patients may be non-responders, raising questions as to the true efficacy of TPTD in improving BMD in osteoporotic patients. The purpose of the study is to determine the rate of improvement in BMD following 18-24months of teriparatide (TPTD) in patients with osteoporosis within an orthopedic hospital setting. This is a retrospective chart review of patients with osteoporosis who completed 18-24months of TPTD therapy. The primary endpoint was the change in BMD at lumbar spine (LS) and hip-femoral neck (FN) and total hip (TH) following treatment. Secondary endpoints included the effect of prior bisphosphonate therapy, age, body mass index (BMI) and family history of fracture on BMD response, and the changes in bone-specific markers during active treatment. Seventy-eight women and men with mean T-scores at the LS = -2.63 met the inclusion criteria. The overall group showed a 10.7% increase in LS-BMD after 24months of TPTD. Eighty-three percent were considered responders defined as ≥3.0% increase in LS-BMD. Non-responders (16.7%) had mean LS-BMD change = -1.41%. No difference in baseline vitamin D, calcium, creatinine, BMI, age, gender, prior fracture history, or bisphosphonate use was observed between responders and non-responders. No consistent pattern of change in measures of bone markers was noted between responders and non-responders. Eighty-three percent of patients with osteoporosis showed a >3% increase in BMD after TPTD treatment. Baseline parameters, prior bisphosphonate therapy, and the changes in bone markers showed no correlation with final BMD outcome.

Efficacy of Teriparatide in Patients with Hypoparathyroidism: A Prospective, Open-label Study.

Context:Conventional treatment of hypoparathyroidism with calcium, Vitamin D analogs, and thiazide diuretics is often suboptimal, and these patients have poor quality of life. Teriparatide (parathyroid hormone 1–34 [PTH (1–34)]), an amide of PTH, is widely available for the use in osteoporosis; however, its use in hypoparathyroidism is limited.Aims:The aim of this study is to evaluate the efficacy of PTH (1–34) in the treatment of patients with hypoparathyroidism.Settings and Design:This was a prospective, open-label interventional study in a tertiary care hospital of Indian Armed Forces.Subjects and Methods:All patients with hypoparathyroidism presented to the endocrinology outpatient department were included and were exhibited injection PTH (1–34) 20 μg twice daily that was gradually reduced to 10 μg twice daily along with calcium, active Vitamin D (alfacalcidol), and hydrochlorothiazide. Oral calcium and alfacalcidol doses were also reduced to maintain serum calcium within normal range. The quality of life (QOL) score was calculated using RAND 36 QOL questionnaire at baseline and termination of the study.Statistical Analysis Used:Paired t-test was used to calculate pre- and post-treatment variables.Results:Eight patients (two males) were included in this study having mean age of 35.8 years. PTH (1–34) treatment led to the improvement in serum calcium (6.81–8.84 mg/dl), phosphorous (5.8–4.2 mg/dl), and 24 h urinary calcium excretion (416–203.6 mg). Parameters of QOL showed the improvement in overall QOL, physical performance, energy, and fatigue scores. No major adverse events were noted.Conclusions:Treatment of hypoparathyroidism with PTH (1–34) leads to improvement in calcium profile, reduction in hypercalciuria, and improvement in QOL, whereas it is safe and well tolerated.

Efficacy of osteoporosis therapy with the short-term use of weekly teriparatide in patients with a fresh fragility fracture

Efficacy of osteoporosis therapy with the short-term use of weekly teriparatide in patients with a fresh fragility fracture

Teriparatide treatment in elderly patients with sacral insufficiency fracture

Pain-related immobility because of insufficiency fractures may result in serious complications and a high mortality rate in senile patients with preexisting comorbidities. This study aimed to evaluate the efficacy of teriparatide in patients with sacral insufficiency fractures. This retrospective, case-controlled, single center study, performed from 2009 to 2014, included 41 patients who underwent radiographs, magnetic resonance imaging, and/or bone scans to document sacral insufficiency fractures. The intervention involved teriparatide at a once-daily subcutaneous dose of 20 μg within 2 days of hospital admission (21 patients). Twenty patients (control group) did not receive teriparatide. Functional outcome was assessed using a visual analog scale for pain and the time to mobilization. Pelvic anteroposterior radiographs were repeated at 0, 1, 4, 8, 12, and 16 weeks until radiographic evidence of cortical bridging at the fracture site was confirmed. From the date of admission to 4 weeks, the mean visual analog scale score improved between the 2 groups. The mean time to mobilization was 1.2 ± 0.4 weeks in patients who received teriparatide treatment, compared with 2.0 ± 0.3 weeks in controls (P < 0.001). At 8 weeks, all fractures in the teriparatide treatment group and 4 fractures in the control group had healed. In senile patients with preexisting comorbidities who have sacral insufficiency fractures, teriparatide treatment may achieve earlier pain reduction and mobilization and reduce healing time.