Mean Percent Change In Bone Mineral Density Research Articles

The effect of daily oral PrEP use during pregnancy on bone mineral density among adolescent girls and young women in Uganda.

Oral pre-exposure prophylaxis (PrEP) is recommended during pregnancy for at-risk cisgender women. Pregnancy is known to impede bone growth and tenofovir-based PrEP may also yield detrimental changes to bone health. Thus, we evaluated the effect of PrEP use during pregnancy on bone mineral density (BMD). We used data from a cohort of women who were sexually active, HIV-negative, ages 16-25 years, initiating DMPA or choosing condoms for contraception and enrolled in the Kampala Women's Bone Study. Women were followed quarterly with rapid testing for HIV and pregnancy, PrEP dispensation, and adherence counseling. Those who became pregnant were counseled on PrEP use during pregnancy per national guidelines. BMD of the neck of the hip, total hip, and lumbar spine was measured using dual-energy x-ray absorptiometry at baseline and annually. We compared the mean percent change in BMD from baseline to month 24. Among 499 women enrolled in the study, 105 pregnancies occurred in 90 women. At enrollment, the median age was 20 years (IQR: 19-21) and 89% initiated PrEP. During pregnancy, 67% of women continued using PrEP and PrEP was dispensed in 64% of visits. BMD declined significantly in women using PrEP during pregnancy compared to women who were not pregnant nor used PrEP: relative BMD change was -2.26% (95% CI: -4.63 to 0.11, p = 0.06) in the femoral neck, -2.57% (95% CI: -4.48 to -0.66, p = 0.01) in total hip, -3.06% (95% CI: -5.49 to -0.63, p = 0.001) lumbar spine. There was no significant difference in BMD loss when comparing PrEP-exposed pregnant women to pregnant women who never used PrEP. Women who became pregnant were less likely to continue PrEP at subsequent study visits than women who did not become pregnant (adjOR: 0.25, 95% CI: 0.16-0.37, p < 0.001). Based on pill counts, there was a 62% reduction in the odds of high PrEP adherence during pregnancy (adjOR = 0.38, 95% CI: 0.27-0.58, p < 0.001). Women who used PrEP during pregnancy experienced a similar reduction in BMD as pregnant women with no PrEP exposure, indicating that BMD loss in PrEP-using pregnant women is largely driven by pregnancy and not PrEP.

Changes in Bone Density in Carriers of BRCA1 and BRCA2 Pathogenic Variants After Salpingo-Oophorectomy.

To evaluate the effect of risk-reducing salpingo-oophorectomy (RRSO) on change in bone mineral density (BMD) in women aged 34-50 years with pathogenic variants in BRCA1 or BRCA2 ( BRCA1 /2). The PROSper (Prospective Research of Outcomes after Salpingo-oophorectomy) study is a prospective cohort of women aged 34-50 years with BRCA1 or two germline pathogenic variants that compares health outcomes after RRSO to a non-RRSO control group with ovarian conservation. Women aged 34-50 years, who were planning either RRSO or ovarian conservation, were enrolled for 3 years of follow-up. Spine and total hip BMD were measured by dual-energy X-ray absorptiometry (DXA) scans obtained at baseline before RRSO or at the time of enrollment for the non-RRSO group, and then at 1 and 3 years of study follow-up. Differences in BMD between the RRSO and non-RRSO groups, as well as the association between hormone use and BMD, were determined by using mixed effects multivariable linear regression models. Of 100 PROSper participants, 91 obtained DXA scans (RRSO group: 40; non-RRSO group: 51). Overall, total spine, and hip BMD decreased significantly from baseline to 12 months after RRSO (estimated percent change -3.78%, 95% CI -6.13% to -1.43% for total spine; -2.96%, 95% CI -4.79% to -1.14% for total hip) and at 36 months (estimated percent change -5.71%, 95% CI -8.64% to -2.77% for total spine; -5.19%, 95% CI -7.50% to -2.87% for total hip. In contrast, total spine and hip BMD were not significantly different from baseline for the non-RRSO group. The differences in mean percent change in BMD from baseline between the RRSO and non-RRSO groups were statistically significant at both 12 and 36 months for spine BMD (12-month difference -4.49%, 95% CI -7.67% to -1.31%; 36-month difference -7.06%, 95% CI -11.01% to -3.11%) and at 36 months for total hip BMD (12-month difference -1.83%, 95% CI -4.23% to 0.56%; 36-month difference -5.14%, 95% CI -8.11% to -2.16%). Across the study periods, hormone use was associated with significantly less bone loss at both the spine and hip within the RRSO group compared with no hormone use ( P <.001 at both 12 months and 36 months) but did not completely prevent bone loss (estimated percent change from baseline at 36 months -2.79%, 95% CI -5.08% to -0.51% for total spine BMD; -3.93%, 95% CI -7.27% to -0.59% for total hip BMD). Women with pathogenic variants in BRCA1 /2 who undergo RRSO before the age of 50 years have greater bone loss after surgery that is clinically significant when compared with those who retain their ovaries. Hormone use mitigates, but does not eliminate, bone loss after RRSO. These results suggest that women who undergo RRSO may benefit from routine screening for BMD changes to identify opportunities for prevention and treatment of bone loss. ClinicalTrials.gov , NCT01948609.

OR01-5 Transition From Low Dose Denosumab 30mg to IV Zoledronic Acid: Effect on Bone Mineral Density in Postmenopausal Women with Osteoporosis: A Prospective Observational Study

Abstract Introduction Cessation of denosumab(Dmab), a fully human monoclonal antibody to RANK-ligand, is associated with rises in bone remodelling, reductions in bone mineral density(BMD) and an increased fracture risk. We previously reported that BMD was stable following a switch from Dmab 60mg to 30mg in postmenopausal women with osteoporosis at a moderate fracture risk(1). The primary objective of this extension study is to evaluate the effect of switching patients from 30mg Dmab(6monthly) to IV Zoledronic acid (ZA), administered 6 months following the last dose of Dmab, in preventing bone loss in postmenopausal women with osteoporosis who are no longer at a high fracture risk. Methods Postmenopausal women with osteoporosis at a moderate or low fracture risk, previously on 30mg of Dmab 6monthly were switched to receive 5mg of IV ZA. Exclusion criteria included an additional skeletal disorder, prior fragility fracture, or use of oral steroids (daily in the past 12months). The primary endpoints were the mean percent change in BMD at the lumbar spine(LS), total hip(TH), femoral neck(FN) and 1/3radius(1/3R), as well as the percent change in alkaline phosphatase(ALP) at 24 months compared to baseline, following transition to IV ZA. Secondary outcomes were clinical fractures. Results 8 patients were included in the study. The mean duration of 30mg Dmab prior switching to IV ZA was 14.6 ± 2.8 months. Mean percent change in BMD at LS was -3.04(CI: 5.77, -0.32, p =0.033) and mean absolute change was -0.025gm/cm2(CI: -0.048, -0.002, p=0.038). The percent change at the TH was -2.64(CI: -4.97, -0.31, p=0.031) with a mean absolute change of -0.021 gm/cm2(CI: -0.040, -0.002, p=0.038). There were no statistically significant changes at the FN, or 1/3R sites at 24months post IV ZA. ALP showed 45.5% increase on average at 24months compared to baseline(95% CI: 14.1, 76.9, p=0.011). No clinical fractures were observed. Conclusions We observed a statistically significant decline in mean percent change in BMD at the LS and TH following a switch from 30mg Dmab to IV ZA at 24months following IV ZA administration. This is similar to the data seen following a switch from standard dose Dmab(60mg 6monthly) to IV ZA(2). The small decline in BMD seen maybe within the precision error of the assessment and this requires further evaluation in a larger number of patients. This was associated with a rise in ALP, however we did not observe any clinical fractures in this study.

Bone mineral density changes among HIV-uninfected young adults in a randomised trial of pre-exposure prophylaxis with tenofovir-emtricitabine or placebo in Botswana.

BackgroundTenofovir-emtricitabine (TDF-FTC) pre-exposure prophylaxis (PrEP) has been found to be effective for prevention of HIV infection in several clinical trials. Two studies of TDF PrEP among men who have sex with men showed slight bone mineral density (BMD) loss. We investigated the effect of TDF and the interaction of TDF and hormonal contraception on BMD among HIV-uninfected African men and women.MethodWe evaluated the effects on BMD of using daily oral TDF-FTC compared to placebo among heterosexual men and women aged 18–29 years enrolled in the Botswana TDF2 PrEP study. Participants had BMD measurements at baseline and thereafter at 6-month intervals with dual-energy X-ray absorptiometry (DXA) scans at the hip, spine, and forearm.ResultsA total of 220 participants (108 TDF-FTC, 112 placebo) had baseline DXA BMD measurements at three anatomic sites. Fifteen (6.8%) participants had low baseline BMD (z-score of <−2.0 at any anatomic site), including 3/114 women (2.6%) and 12/106 men (11.3%) (p = 0.02). Low baseline BMD was associated with being underweight (p = 0.02), having high blood urea nitrogen (p = 0.02) or high alkaline phosphatase (p = 0.03), and low creatinine clearance (p = 0.04). BMD losses of >3.0% at any anatomic site at any time after baseline were significantly greater for the TDF-FTC treatment group [34/68 (50.0%) TDF-FTC vs. 26/79 (32.9%) placebo; p = 0.04]. There was a small but significant difference in the mean percent change in BMD from baseline for TDF-FTC versus placebo at all three sites at month 30 [forearm −0.84% (p = 0.01), spine −1.62% (p = 0.0002), hip −1.51% (p = 0.003)].ConclusionUse of TDF-FTC was associated with a small but statistically significant decrease in BMD at the forearm, hip and lumbar spine. A high percentage (6.8%) of healthy Batswana young adults had abnormal baseline BMD Further evaluation is needed of the longer-term use of TDF in HIV-uninfected persons.Trial RegistrationClinicalTrials.gov NCT00448669

Efficacy and safety of risedronate 150-mg once a month in the treatment of postmenopausal osteoporosis: 2-year data

SummaryThis study showed that risedronate 150-mg once a month provides similar efficacy and safety at 2 years compared with risedronate 5-mg daily for the treatment of postmenopausal osteoporosis. This adds to the range of risedronate dosing options and provides an alternative for patients who prefer once-a-month dosing.IntroductionRisedronate is effective in the treatment of postmenopausal osteoporosis in oral daily, weekly, or on two consecutive days per month doses. This 2-year randomized, double-blind, multicenter study assesses the efficacy and safety of a single risedronate 150-mg once-a-month oral dose compared with the 5-mg daily regimen.MethodsWomen with postmenopausal osteoporosis were randomly assigned to receive risedronate 5-mg daily (n = 642) or 150-mg once a month (n = 650) for 2 years. Bone mineral density (BMD), bone turnover markers, new vertebral fractures, and adverse events were evaluated. The primary efficacy endpoint was the mean percent change from baseline in lumbar spine BMD after 1 year.ResultsFour hundred ninety-eight subjects in the daily group (77.6 %) and 513 subjects in the once-a-month group (78.9 %) completed the study. After 24 months, the mean percent change in lumbar spine BMD was 3.9 % (95 % confidence interval [CI], 3.43 to 4.42 %) and 4.2 % (95 % CI, 3.68 to 4.65 %) in the daily and once-a-month groups, respectively. The once-a-month regimen was determined to be non-inferior to the daily regimen. The mean percent changes in BMD at the hip were similar in both dose groups, as were changes in biochemical markers of bone turnover. The incidence of adverse events, adverse events leading to withdrawal, and upper gastrointestinal tract adverse events were similar in the two treatment groups.ConclusionsAfter 2 years, treatment with risedronate 150-mg once a month provided similar efficacy and tolerability to daily dosing and provides an alternative for patients who prefer once-a-month oral dosing.

Longitudinal analysis of vertebral fracture and BMD in a Canadian cohort of adult cystic fibrosis patients

BackgroundVertebral fractures in patients with cystic fibrosis (CF) may contribute to an accelerated decline in lung function and can be a contraindication to lung transplantation. In this study, we examined longitudinal change in bone mineral density (BMD) and the prevalence of vertebral fractures in adult CF patients, without lung-transplant, attending a Canadian specialty clinic.MethodsRetrospective chart review of all patients attending an Adult Cystic Fibrosis Clinic at Hamilton Health Sciences in Hamilton, Canada. Forty-nine of 56 adults met inclusion criteria. Chest radiographs were graded by consensus approach using Genant's semi-quantitative method to identify and grade fractured vertebrae. Dual x-ray absorptiometry (DXA) scans were also reviewed.ResultsThe mean age of the cohort was 25.2 years (SD 9.4), 43% were male. The mean body mass index (BMI) was 19.8 (2.8) for males and 21.7 (5.1) for females. At baseline, the rate of at least one vertebral fracture was 16.3%; rising to 21.3% (prevalent and incident) after a 3-year follow-up. The mean BMD T-or Z-scores at baseline were -0.80 (SD 1.1) at the lumbar spine, -0.57 (SD 0.97) at the proximal femur, and -0.71 (SD 1.1) at the whole body. Over approximately 4-years, the mean percent change in BMD was -1.93% at the proximal femur and -0.73% at the lumbar spine.ConclusionApproximately one in five CF patients demonstrated at least one or more vertebral fractures. Moderate declines in BMD were observed. Given the high rate of vertebral fractures noted in this cohort of adult CF patients, and the negative impact they have on compromised lung functioning, regular screening for vertebral fractures should be considered on routine chest radiographs.

Influence of type 2 diabetes mellitus on bone mineral density response to bisphosphonates in late postmenopausal osteoporosis

Bisphosphonates are effective agents for postmenopausal osteoporosis, but their efficacy in patients with type 2 diabetes mellitus (DM) is not known. The investigators evaluated bone mineral density (BMD) response to alendronate in women with concurrent late postmenopausal osteoporosis and type 2 DM. In a retrospective, matched case-control study, 26 late postmenopausal osteoporotic women with type 2 DM (age, 67.6+/-7.3 y; type 2 DM duration, 12.8+/-6.8 y; duration of menopause, 10.9+/-7.4 y; time on alendronate: 4.8+/-2.3 y; body mass index [BMI], 31.4+/-6.3 kg/m2) were matched with 26 controls according to age, BMI, duration of menopause, and alendronate treatment received. All subjects were given alendronate 10 mg/d or 70 mg/wk, along with sufficient vitamin D (>or=400 IU) and calcium (>or=1 g/d) intake, for 4.8 y. Response to alendronate therapy was determined by assessment of mean percent change in BMD of total hip, femoral neck, forearm, and lateral spine. The presence of type 2 DM resulted in no difference in spinal BMD response to alendronate therapy. In contrast, BMD in the total hip (mean percent change in BMD, -5.6% vs +1.4%; P=.096), femoral neck (-8.1% vs +1.1%; P=.015), and forearm (-3.6% vs +12.7%; P=.013) fell progressively from baseline in subjects with type 2 DM who were taking alendronate for 4.8 y, compared with controls. Elderly, postmenopausal, osteoporotic obese women with type 2 DM are resistant to long-term bisphosphonates, especially in regions of the hip, femoral neck, and forearm compared with the spine. The efficacy of bone resorption inhibitors in patients with type 2 DM, especially in comparison with anabolic agents, should be considered in additional studies.

Monthly dosing with risedronate 50 mg on three consecutive days a month compared with daily dosing with risedronate 5 mg: a 6-month pilot study

ABSTRACTObjective: Risedronate 5 mg daily significantly reduces the incidence of vertebral and non-vertebral osteoporotic fractures in postmenopausal women. We compared the efficacy and tolerability of risedronate 50 mg administered on 3 consecutive days per month, with and without a loading dose, with those of risedronate 5 mg daily in a randomized, double-blind study.Methods: Subjects were postmenopausal women 65–80 years old with low bone mineral density (BMD) (T-score ≤ –2). Subjects received risedronate 5 mg daily for 6 months (n = 48), risedronate 150 mg (50-mg doses on 3 consecutive days) monthly for 6 months (n = 50), or a loading dose of risedronate 15 mg daily for 1 month followed by 150 mg (50-mg doses on 3 consecutive days) monthly for 5 months (n = 52).Results: Within 1 week, statistically significant reductions in urine N-telopeptide, the primary efficacy measure, were observed in all three groups. After 6 months, the least squares (LS) mean differences (95% confidence intervals [CI]) from the change in the 5 mg daily group (–39.88) were –3.54% (–15.71; 8.64) for the 150 mg monthly and –2.02% (–14.13;10.10) for the loading dose + 150 mg monthly groups. Mean percent changes in serum alpha-C-telopeptide, bone-specific alkaline phosphatase, and BMD, secondary efficacy measures, after 6 months were also similar for the three groups. The LS mean differences (95% CI) from the mean percent change in BMD in the 5 mg daily group (3.22%) were 0.20 (–1.15; 1.55) for the 150 mg monthly and –0.58 (–1.93; 0.76) for the loading dose + 150 mg monthly groups. The safety profile of the monthly regimens was similar to that of the 5 mg daily regimen and consistent with product labeling.Conclusions: A monthly regimen of risedronate 50 mg on 3 consecutive days per month was similar to risedronate 5 mg daily with respect to its effect in suppressing bone turnover and increasing BMD and its safety profile in women with postmenopausal osteoporosis. This study was not powered to be a confirmatory trial for non-inferiority; therefore, additional study is needed.

Depressive symptoms and bone mineral density in older men.

Most studies examining the relation between depression and bone mineral density (BMD) have been limited to psychiatric patients or to community-dwelling, older women. We conducted a cross-sectional and prospective cohort study to determine whether depressive symptoms are associated with low BMD in community-dwelling, older men. We recruited 515 men 50 years of age or older from population-based listings of age-eligible men. Participants completed the Geriatric Depression Scale (short form) and were considered depressed if they scored 6 or more out of 15 possible points. BMD was measured in the spine and hip using dual energy x-ray absorptiometry in all participants, and again an average of 3.6 years later in a random subset of 100 participants. The prevalence of depressive symptoms (GDS = 6) was 3.1% (16 of 515). We found no difference in mean BMD or mean percent change in BMD per year of the hip and lumbar spine in men who had 6 or more depressive symptoms compared with men who reported 5 or fewer symptoms of depression. These findings suggest that depressive symptoms are not associated with BMD in community-dwelling, older men.

Effect of exercise training and detraining on bone mineral density in postmenopausal women with osteoporosis

We examined the effect of exercise training and detraining on bone mineral density (BMD) in postmenopausal women with osteoporosis. Thirty-five postmenopausal women with osteoporosis, aged 53–77 years, were randomly assigned to three groups: a control group (n=20), a 2-year exercise training group (n=8), and an 1-year exercise training plus 1-year detraining group (n=7). Exercise training consisted of daily brisk walking and gymnastic training. Calcium lactate, 2.0 g, and 1α-hydroxyvitamin D3, 1 μg were supplied daily to all subjects. No significant differences in initial lumbar BMD, measured by dual-energy X-ray absorptiometry (DXA) were found among the three groups. The mean percent change in BMD compared with the baseline was significantly higher at 1 and 2 years in the exercise training group and at 1 year in the detraining group than in the control group, and did not differ significantly at 2 years between the detraining and control groups. These findings indicate that our exercise training program led to a significant increase in lumbar BMD in postmenopausal women with osteoporosis compared with the control, but that the BMD reverted toward a level that was not significantly different from the control with detraining. Continued exercise training is needed to maintain the bone mass gained through exercise training.

Alendronate increases lumbar spine bone mineral density in patients with Crohn's disease

Background & Aims: Low bone mineral density (BMD) is a common complication of Crohn's disease and may lead to increased morbidity and mortality because of fractures. We investigated the effect of treatment with the bisphosphonate alendronate on bone mass and markers of bone remodeling in patients with Crohn's disease. Methods: A 12-month double-blind, randomized, placebo-controlled trial examined the effect of a 10-mg daily dose of alendronate. Thirty-two patients with a bone mass T score of −1 of the hip or lumbar spine were studied. The main outcome measure was the difference in the mean percent change in BMD of the lumbar spine measured by dual-energy x-ray absorptiometry. Secondary outcome measures included changes in BMD of the hip and total body and biochemical markers of bone turnover (S-osteocalcin, urine pyridinoline, and urine deoxypyridinoline excretion). Results: Mean (±SEM) BMD of the lumbar spine showed an increase of 4.6% ± 1.2% in the alendronate group compared with a decrease of 0.9% ± 1.0% in patients receiving placebo (P < 0.01). BMD of the hip increased by 3.3% ± 1.5% in the alendronate group compared with a smaller increase of 0.7% ± 1.1% in the placebo group (P = 0.08). Biochemical markers of bone turnover decreased significantly in the alendronate group (P < 0.001). Alendronate was well tolerated, and there was no difference in adverse events among treatment groups. Conclusions: Treatment with alendronate, 10 mg daily, significantly increased BMD in patients with Crohn's disease and was safe and well tolerated.GASTROENTEROLOGY 2000;119:639-646

Effect of ipriflavone on bone mineral content in osteoporotic patients

Although numerous studies have demonstrated that ipriflavone prevents bone loss, its effect on bone mass remains to be quantitatively assessed by dual-energy x-ray absorptiometry (DXA), a recently developed diagnostic technique which enables precise measurement of bone mineral density (BMD). In this study, we investigated the effect of ipriflavone on BMD in female outpatients with osteoporosis by means of DXA and single-photon absorptiometry (SPA). The study group consisted of 23 female patients with postmenopausal or senile osteoporosis (age: 50–80 years, mean 62.4 years; body weight: 39–63 kg, mean 49.2 kg; height: 145–163 cm, mean 150.8 cm). Nineteen untreated female outpatients (age: 61–65 years) served as a control group. BMD of L1-4 in both the study and control groups was measured by DXA before and after 1 year of treatment with and without ipriflavone (600 mg/day per os), but only 19 of the study group patients were evaluated for BMD by SPA at the radius. For DXA, the mean BMD in the study group was 0.651 g/cm2 before ipriflavone treatment and 0.647 g/cm2 after treatment, with a mean percent change in BMD of 99.5%. For SPA, the mean BMD was 0.495 g/cm2 before ipriflavone treatment and 0.504 g/cm2 after treatment, with a mean percent change in BMD of 101.6%. For patients in the study group aged 61–65 years (n=9), the mean percent change in BMD by DXA after 1 year of treatment was 101.6%. In contrast, the mean percent change in BMD for the control patients of the same age bracket (n=19) was 96.5%. The results by DXA confirmed that ipriflavone inhibits loss of bone mass, making it a useful agent for the treatment of postmenopausal and senile osteoporosis.