Oral Alendronate Treatment Research Articles

Oral bisphosphonate treatment in patients with Duchenne muscular dystrophy on long term glucocorticoid therapy

Osteoporosis is a major problem in patients with Duchenne muscular dystrophy (DMD), due to glucocorticoid therapy and muscle weakness. Evidence on which to base optimal prevention and treatment strategies, including bisphosphonate use, in DMD are limited. Our objective was to describe bone health outcomes of oral alendronate treatment in patients with DMD and glucocorticoid-induced osteoporosis. We retrospectively studied 54 patients treated between 2005 and 2017, and assessed changes in dual-energy x-ray absorptiometry (DXA) whole body and lumbar spine bone mineral density and content, and lateral distal femur bone mineral density. We also examined vertebral fracture development in a subset with serial spine radiographs. Pre-alendronate DXA Z-score trajectories decreased progressively. Over three years post-alendronate initiation, Z-score trajectories improved (p<0.01) at most sites compared with pre-alendronate trajectories. Height-adjusted Z-score trajectories for lumbar spine bone mineral density (p = 0.01) and whole body bone mineral content (p = 0.0004) also improved. The positive trajectories did not seem to be sustained long term in those treated up to 6 years. Radiographic vertebral findings in 43 patients appeared stable. In conclusion, oral bisphosphonate therapy using alendronate was associated with improvement of DXA bone health indices during the first three years of treatment, and may help mitigate progression of osteoporosis in glucocorticoid-treated patients with DMD.

Sekonder Osteoporozlu Hastalarda Günlük ve Haftalık Oral Alendronat Tedavisinin Etkinliğinin Karşılaştırılması

Sekonder Osteoporozlu Hastalarda Günlük ve Haftalık Oral Alendronat Tedavisinin Etkinliğinin Karşılaştırılması

Bilateral patellar fractures and increased cortical bone thickness associated with long-term oral alendronate treatment in a cat

Case summaryA 14-year-old cat presented with bilateral patellar fractures and radiographically thickened tibial cortices. This cat had been treated with alendronate for 8 years prior to presentation. To remove the subjectivity of the radiographic evaluation, tibial radiographs from 35 apparently healthy geriatric cats were used for comparison. Cortical and diaphyseal thickness were measured at the proximal and distal thirds of the tibia. Our cat had increased cortical bone thickness compared to that of the control cats.Relevance and novel informationTreatment with bisphosphonates can lead to brittle bones and fractures after prolonged use in humans. This is the first description of fractures and cortical bone changes that may have been associated with prolonged bisphosphonate use in a cat. Radiographic measurements of cortical bone thickness may identify cats that are at increased risk for bone pathology secondary to prolonged alendronate use.

Cost-Minimization Study Comparing Annual Infusion of Zoledronic Acid or Weekly Oral Alendronate in Women With Low Bone Mineral Density

Cost-minimization study to assess the annual direct costs of 2 antiresorptive strategies in postmenopausal women with low bone mineral densities (BMDs). Patients were randomly assigned to receive 70mg of oral weekly alendronate or a 1-time 5mg of intravenous zoledronic acid. All medical and nonmedical direct costs were recorded for 1yr. Student's t-test or the Chi-squared test was used. A total of 101 postmenopausal women were enrolled with a mean age of 58.3±7.6yr and a postmenopausal period of 13.5±8.3yr. A total of 50 patients completed 1yr of alendronate and 51 patients received zoledronic acid. At baseline, no differences were seen between the 2 groups in anthropometric measures, comorbidities, and bone mineral density. The costs for medical attention for low bone mass were $81,532 (US Dollars) for the alendronate group and $69,251 for the zoledronic acid group; the cost per patient was $1631 in the alendronate group vs $1358 in the zoledronic acid group (p<0.0001). Therefore, zoledronic acid treatment provided an annual savings of 15% of the direct costs compared with oral alendronate treatment. Moreover, there was a significant increase in lumbar spine T-scores in the zoledronic acid group when compared with the alendronate group. Annual zoledronic acid infusion as an antiresorptive treatment in women with low BMD provides significant monetary savings when compared with weekly alendronate therapy for 1yr. Zoledronic acid infusion is also linked to higher increase in BMD and compliance.

Quantitative computed tomography assessment of bone mineral density after 2 years’ oral bisphosphonate treatment in postmenopausal osteoarthritis patients who underwent total knee arthroplasty

To identify the effects of two years' oral bisphosphonate (alendronate) treatment in patients who underwent total knee arthroplasty (TKA); to determine whether significant responses seen after the first year of treatment changed during the second year. Additionally, the study tried to identify factors relating to bone mineral density (BMD) changes. This was a prospective 2-year follow-up study of a previous 1-year report of postmenopausal women with knee osteoarthritis who underwent primary unilateral or staged bilateral TKA, after which they received 70 mg alendronate orally once-weekly. BMD was measured using quantitative computed tomography (QCT) on lumbar vertebrae at baseline (pre-TKA) and at 12 and 24 months. Factors associated with BMD changes were determined by regression analysis. Sixty-one patients entered the second year and continued treatment for ≥ 24 months. Mean vertebral QCT BMDs at baseline and after 12 and 24 months' alendronate treatment were 71.8 mg/ml (41.9-97.5 mg/ml), 69.3 mg/ml (31.4-103.9 mg/ml), and 72.7 mg/ml (33.1-136.1 mg/ml), respectively. Patients undergoing bilateral TKA and who had more severe OA at baseline (bilateral severe [grade 4] OA) had a lower BMD response after 2 years' bisphosphonate treatment, compared with patients with less severe unilateral knee OA who underwent unilateral TKA. Improvements were, however, seen compared with year 1 levels. Low BMI was associated with BMD nonresponse. Patients with bilateral severe OA (grade 4) requiring bilateral knee replacement are at greater risk of nonresponse after 2 years' oral alendronate treatment. A longer duration of treatment may be necessary in these patients.

Atypical Femoral Fractures Shortly After Osteonecrosis of the Jaw in a Postmenopausal Woman Taking Alendronate for Osteoporosis

Bisphosphonates effectively increase bone mineral density and reduce fracture risk in patients with osteoporosis, but there are concerns about osteonecrosis of the jaw (ONJ) and atypical femoral fractures (AFFs) in the long-term users. So far both complications have not been reported as occurring simultaneously in an osteoporotic individual on oral alendronate. The aim of this study was to report a postmenopausal woman presenting with concomitant ONJ and AFF on oral alendronate treatment. SUBJECT, MEASURES, AND RESULT: The patient was a 63-year-old woman with a history of rheumatoid arthritis for 30 years and diabetes for 3 years. Spinal compression fractures at levels L3 and L4 were documented, and she took alendronate 70 mg weekly for 7 years. She is the first case whose dental periapical imaging and pelvic radiography documented her ONJ and AFF, which developed subsequently within 6 months. This case report supports the association of both ONJ and AFF with long-term oral bisphosphonate therapy.

Demographic and clinicopathologic characteristics of breast cancer patients with history of oral alendronate use.

e11093 Background: Bisphosphonates therapy reduces the risk of skeletally related complications in patients with bone metastases due to malignancy and bisphosphonates are the most common used agents in the treatment of osteoporosis. However, the effect on clinical and pathological properties of breast cancer with using oral alendronate has not been reported. We investigate retrospectively the demographic and clinico-pathological characteristics of patients with oral alendronate users for longer than 1 year, compared to non-users. Methods: Patients with breast cancer diagnosed from 1998 to 2010 in our clinic were retrospectively analyzed. Patient’s demographics including survival data and tumor characteristics were obtained from medical charts. Breast cancer patients who were taking oral alendronate more than 12 months at the time of breast cancer diagnosis were enrolled as an alendronate users (n=44), where the patients matched with the same age who were not taking oral alendronate were included as a control group (n=444). Results: A total of 488 patients were included in this study. Forty-four patients received an oral alendronate treatment more than one year and 444 patients were considered as nonusers. Median age of both alendronate users and nonusers was 57 (33-89). Lower incidence histological grade III, T3-T4 tumor, and node positivity was seen in alendronate users but not statistically significant. A similar trend for lower incidence of triple negative and higher incidence ER (P=0.13), PR (P=0.12) and HER2 positivity (P=0.21) was also seen in alendronate users but not statistically significant. Disease free survival rate was 150±28 months in alendronate users where as 70±24 months in nonusers (P=0.015). Median overall survival rates could not be obtained but higher in alendronate users but not statistically significant (P=0.13). Conclusions: The use of oral alendronate for longer than one year before the diagnosis of breast cancer was associated with better clinico-pathological properties and significantly improved disease free survival in breast cancer patients.

Demographic and clinico-pathological characteristics of breast cancer patients with history of oral alendronate use

Bisphosphonates are the most commonly used agents in the treatment of osteoporosis, and bisphosphonate therapy reduces the risk of skeletally related complications in patients with bone metastases due to malignancy. However, the effect of oral alendronate treatment on clinical and pathological properties of breast cancer has not been reported. Thus, we aimed to investigate retrospectively the demographic and clinico-pathological characteristics of new diagnosis of breast cancer patients with oral alendronate users for longer than 1 year, compared with non-users. Newly diagnosed breast cancer patients from 1998 to 2010 in our clinic were retrospectively analyzed. Patient's demographics, including survival data and tumor characteristics, were obtained from medical charts. Breast cancer patients who were taking oral alendronate more than 12 months at the time of breast cancer diagnosis were enrolled as an alendronate users (n=44), where the patients matched with the same age who were not taking oral alendronate were included as a control group (n=444). A total of 488 patients were included in this study. Forty-four patients received an oral alendronate treatment more than 1 year, and 444 patients were considered as non-users. Median age of both alendronate users and non-users was 57 (33-89). Lower incidence of histological grade III, T3-T4 tumor, and node positivity was seen in alendronate users but not statistically significant. A similar trend for lower incidence of triple negative and higher incidence ER (P=0.13), progesterone receptor (P=0.12), and HER2 positivity (P=0.21) was also seen in alendronate users but not statistically significant. Estimated median disease-free survival was 150 months in alendronate users where as 70 months in non-users (P=0.015). Five-year survival rate in alendronate users was 97.4%, whereas in non-users was 89.8% (P=0.13). The use of oral alendronate for longer than 1 year at the time of breast cancer diagnosis was associated with better clinico-pathological properties and significantly improved disease-free survival in breast cancer patients.

Comparison of oral alendronate versus prednisolone in treatment of infants with vitamin D intoxication

The aim of this report was to compare the efficacy of oral alendronate versus prednisolone treatment in addition to conventional measures in infants with vitamin D intoxication. In six infants (aged 8.0 ± 2.1 months) with vitamin D intoxication, time to achieve normocalcemia with prednisolone treatment (Group I, n = 4) or alendronate treatment (Group II, n = 4, two infants started treatment from the baseline and two after unsuccessful prednisolone treatment) in addition to intravenous hydration and diuretic therapy were compared. Baseline serum calcium levels ranged between 3.8 and 4.77 mmol/L. In the prednisolone group, although two patients reached normocalcemia on 7th and 12th days of treatment, other two patients did not despite 23 and 15 days of treatment and therefore switched to alendronate treatment. The mean duration of prednisolone treatment in these four patients was 14.2 ± 6.7 days (range 7-23). In the alendronate group, two patients who started treatment from the baseline achieved normocalcemia on the 5th day. Other two patients achieved normocalcemia 2 days after switching to alendronate. Thus, the mean time to reach normocalcemia after single oral alendronate administration was 3.5 ± 1.7 days (range 2-5) (p < 0.01 versus Group I). Alendronate treatment achieves normocalcemia four times earlier than prednisolone treatment and shortens hospital stay in infants with vitamin D intoxication.

Long-term efficacy of oral alendronate therapy in an elderly patient with polyostotic fibrous dysplasia: A case report

Polyostotic fibrous dysplasia (PFD) is a high- turnover bone disease that frequently entails chronic bone pain, pathological fractures and severe deformities. Recently, bisphosphonates have shown effective antiresorptive properties in the treatment of children or adults with PFD. We report on a 79-year-old female with PFD, who had severe lower limb deformity and chronic bone pain in multiple sites of her extremities for more than 55 years. The patient experienced significant decrease in bone pain and bone turnover markers following long-term (8.5 years) treatment with a low-dose oral alendronate treatment (5 mg/day). To the best of our knowledge, this is the first report of a long-term follow-up of a postmenopausal elderly patient with long-standing symptomatic PFD following continuous low-dose oral alendronate therapy. This case report indicates that long-term daily administration of low-dose alendronate alone is a potential treatment option for elderly patients with PFD, particularly those with long-standing bone pain.

Alendronate for the treatment of hypercalcaemia due to neonatal subcutaneous fat necrosis

Dear Editor, We read with great interest the article by Mitra et al. [3] who described subcutaneous fat necrosis (SCFN) in a preterm infant after severe perinatal hypoxic injury complicated by hypercalcaemia. Mitra et al. [3] state that significant SCFN can develop in both preterm and term infants and preterm infants also develop significant complications including hypercalcaemia. Most patients can be treated successfully by hyperhydration, furosemide, corticosteroids, and also by citrate, calcitonin, and bisphosphonates [4, 5]. Among the bisphosphonates, both etidronate [4] and pamidronate [2] have been used in the treatment of hypercalcaemia due to SCFN of the newborn. However, the use of alendronate for this purpose has not been reported yet, as far as we know. Alendronate as a bisphosphonate is a potent inhibitor of osteoclast-mediated bone resorption. Previously, it has been used safely in patients with hypercalcaemia associated with vitamin D intoxication [1]. Recently, we successfully treated with alendronate sodium a patient with hypercalcaemia associated with SCFN after a severe perinatal asphyxic event. In our patient, the indurated erythematous plaques and nodules appeared on the back, upper arm and gluteal areas by postnatal day 7 (Fig. 1). When the lesions had almost disappeared on postnatal day 30, serum calcium level still reached a peak of 11.5 mg/dL with a urine calcium/urine creatinine ratio of 0.74 mg/mg. Laboratory testing showed serum parathyroid hormone level of 7.5 pg/mL (normal range, 15–65 pg/mL) and serum 25-hydroxyvitamin D level of 38.5 ng/mL (normal range, 10–40 ng/mL). Because of the clear clinical findings, a histopathological examination was not required. Renal ultrasonography showed bilaterally punctiform renal medullary hyperechogenicities. Despite adequate hydration, the patient’s serum calcium level remained high. Because the degree of hypercalcaemia was mild and there was nephrocalcinosis, furosemide treatment was not chosen in our patient. Moreover, corticosteroids were not considered because of their potential side effects. Hence, the bisphosphonate treatment was intended and then, because availability of oral preparation, the patient was given oral alendronate at a dosage of 5 mg/day. Oral alendronate treatment was discontinued on postnatal day 50 when the serum calcium level and urinary calcium/ creatinine ratio had returned to normal. During the alendronate therapy, no side effects were observed. In conclusion, patients with SCFN should be closely monitored for developing metabolic problems like hypercalcaemia. Moreover, alendronate can be used safely and effectively in the treatment of hypercalcaemia associated with SCFN. N. Hakan :M. Aydin (*) :A. Zenciroglu :N. Demirel : N. Okumus :M. S. Ipek Department of Neonatology, Dr. Sami Ulus Maternity and Children’s Hospital, Babur Street, no: 44 (06080) Altindag, Ankara, Turkey e-mail: dr1mustafa@hotmail.com

Oral Alendronate Treatment for Severe Polyostotic Fibrous Dysplasia due to McCune-Albright Syndrome in a Child: A Case Report

Polyostotic fibrous dysplasia (FD) associated to McCune-Albright Syndrome (MAS) often leads to fractures, deformities, and bone pain resulting in bad quality of life. Parenteral bisphosphonates have been used in children and adolescents to improve these symptoms with few adverse effects. We evaluated the response to oral Alendronate in a girl with severe MAS FD and observed improved quality of life with reduction of bone pain.

Oral Alendronate Treatment for Severe Polyostotic Fibrous Dysplasia due to McCune-Albright Syndrome in a Child: A Case Report

Oral Alendronate Treatment for Severe Polyostotic Fibrous Dysplasia due to McCune-Albright Syndrome in a Child: A Case Report

The effect of 6 months oral alendronate treatment on periprosthetic bone loss after total knee arthroplasty

Objective This study was designed to test whether established post-total knee arthroplasty (TKA) bone loss at over 2 years post-surgery could be improved by 6 months of alendronate administration.

A probable case of oral bisphosphonate-associated osteonecrosis of the jaw and recovery with parathyroid hormone treatment

Introduction: Bisphosphonates are effective for treating osteoporosis, Paget's disease of bone, and malignancy-associated bone diseases. Bisphosphonate-associated osteonecrosis of the jaw (ONJ) is a rare but serious adverse effect of bisphosphonate therapy. Due to inhibitory actions on bone turnover, bisphosphonate therapy may result in the accumulation of microdamage. Case summary: A 74-year-old Korean woman (height, 150 cm; weight, 51 kg) was referred to the Department of Endocrinology and Metabolism, Ajou University School of Medicine, Suwon, South Korea, for evaluation of pain and persistent abnormal exposure of jaw bone after extraction of teeth. She had been receiving weekly oral alendronate treatment for osteoporosis for ~5 years. The patient had the clinical features of bisphosphonate-associated osteonecrosis of the mandible, which was precipitated by teeth extraction ~14 months prior to the outpatient referral visit. At her clinical baseline visit, serum hormone concentrations and bone turnover markers were as follows: thyroid-stimulating hormone, 0.88 μIU/mL (reference range, 0.25–5.00 μIU/mL); 25-hydroxyvitamin D 3, 20.9 (9.0–37.6) ng/mL; parathyroid hormone (PTH), 57 (11–62) pg/mL; serum osteocalcin, 8.7 (12.9–55.9) ng/mL; and urine N-telopeptide 21 (26–124) nM/mM creatinine. She had multiple systemic risk factors for ONJ, including older age, type 2 diabetes mellitus, and long duration of bisphosphonate therapy. There was no mandibular lesion improvement despite repeated surgical procedures performed within a 14-month period. Bisphosphonate therapy was discontinued and PTH therapy was started. After 2 months, exposed oral mucosa had healed. After 4 months of treatment, the pain had completely subsided, and after 6 months the patient's eating and drinking habits returned. The serum concentration of osteocalcin, a bone formation marker, which was initially suppressed (8.7 ng/mL), increased 174% (15.1 ng/mL) from baseline after 6 months of treatment with PTH. Conclusions: Here we report a probable case of oral bisphosphonate-associated ONJ featuring suppressed bone turnover. Treatment with the bone formation-stimulating agent PTH was beneficial.

Systemic alendronate treatment improves fixation of press‐fit implants: A canine study using nonloaded implants

Bone resorption associated with local trauma occurring during insertion of joint prostheses is recognized as an early event. Being an osteoclastic inhibitor, alendronate is a potential candidate means to decrease early periprosthetic bone resorption and thereby improve implant fixation. We investigated the influence of oral alendronate treatment on early implant fixation in two implant interface settings representing sites of an implant that are in contact with surrounding bone, and other sites without intimate bone contact. One plasma-sprayed cylindrical titanium implant (6 mm diameter) was inserted into each proximal tibia of 16 dogs. On one side the implant was inserted press-fit whereas on the contralateral side, the implants were surrounded by a 2 mm concentric gap. Oral alendronate (0.5 mg/kg/day) was given 2 weeks following surgery to eight dogs. The dogs were euthanized after 10 weeks of alendronate treatment. Bone ongrowth (bone in contact with implant surface) was estimated using the linear intercept technique and shear strength was calculated as the slope on a load-displacement curve. For the press fit implants, alendronate treatment significantly increased bone ongrowth from 24% to 29% and significantly increased ultimate shear strength from 1.26 to 3.72 MPa. Also, the fraction of periprosthetic bone significantly increased from 10% to 18%. For implants surrounded by a gap, alendronate neither stimulated nor impaired implant fixation, bone ingrowth, or new bone formation in the gaps. Because early implant stability is an important predictor of longevity, systemic alendronate treatment could be an important clinical tool to positively influence the early stages of implant incorporation.

Efficacy of Oral Alendronate in Children With Osteogenesis Imperfecta

The purpose of this study was to investigate the efficacy of oral alendronate for children with osteogenesis imperfecta. Nine boys and seven girls of average age 9.5 years were given oral alendronate for an average of 4 years. Fracture frequency decreased, and in more than half of the patients the ambulatory/mobility status improved. Bone mineral density improved significantly, and restoration of collapsed vertebral bodies was observed. Urinary excretion of calcium and a bone resorption marker decreased significantly. Iliac crest physis biopsy showed an expanded primary spongiosa area with numerous multinucleated cells. This study reveals that oral alendronate caused biochemical, radiologic, and histologic changes along with clinical improvement. Oral alendronate treatment, which is convenient for the school-age group, was found to be a tolerable and efficacious treatment for children with moderate or severe osteogenesis imperfecta.

Effect of Alendronate on Periodontal Disease in Postmenopausal Women: A Randomized Placebo‐Controlled Trial

We investigated the effect of oral alendronate (ALN) treatment on radiological and clinical measurements of periodontal disease in postmenopausal women without hormone replacement therapy. We evaluated the effect of 6 months of ALN treatment in 40 postmenopausal women, 55 to 65 years old with established periodontal disease, in a controlled, double-masked, prospective study. Volunteers were paired by age and randomized to receive ALN (10 mg/day) or placebo for the study period. Periodontal mechanical treatment was carried out in both groups. At baseline and after treatment, clinical evaluation, hormone blood levels, distance from the crestal alveolar bone (CAB) to the cemento-enamel junction (CEJ), calcaneus bone mineral density (BMD), hormone levels, serum N-telopeptide (NTx), and bone-specific alkaline phosphatase (BSAP) were assessed. Periodontal disease conditions improved in both groups, but greater improvement in probing depth (-0.8 +/- 0.3 mm versus -0.4 +/- 0.4 mm, P = 0.02) and gingival bleeding (-0.3% +/- 0.13% versus -0.2% +/- 0.06%, P = 0.006) was found in the ALN treated group. Calcaneus BMD increased in the ALN treated group (68 +/- 47 mm3 versus -26 +/- 81 mm3, P = 0.0006). CAB-CEJ distance diminished in the ALN group (-0.4 +/- 0.40 mm versus 0.60 +/- 0.53 mm, P = 0.00008). Marginal reduction in both NTx and BSAP levels was found in the ALN group (-9.4 +/- 6.6 nmol versus -4.3 +/- 4.7 nmol bone collagen equivalents, P = 0.08, and -7.7 +/- 8.4 versus -1.5 +/- 5.0 U/l, P = 0.1, respectively). Hormone levels were unchanged after treatment. Similar improvement of calcaneus BMD and CAB-CEJ distance with ALN treatment was found in obese and non-obese women. ALN treatment improved periodontal disease and bone turnover in postmenopausal women.

Oral alendronate treatment for polyostotic fibrous dysplasia: a case report

AbstractRecently, intravenous therapy with pamidronate has been reported to be effective for treating fibrous dysplasia. However, very little is known about the efficacy of oral alendronate for fibrous dysplasia. We describe a patient with polyostotic fibrous dysplasia, who had complained of persistent pain for more than 20 years, that was treated with oral alendronate alone. Follow-up examinations were at intervals of 3 months for 2 years. The pain, radiographic findings, and bone turnover, which was monitored using various markers, improved. No adverse side effect was noted. Oral alendronate is suggested to be a useful option in the treatment of polyostotic fibrous dysplasia.

Effect Of Alendronate Treatment On Bone Mineral Density In Male Patients With Osteoporosis

To assess the efficacy of alendronate therapy on bone mineral density (BMD) at the lumbar spine and hip in men with osteoporosis. Medical records of male patients with osteoporosis, who had undergone follow-up in the Endocrinology Clinic at the National Naval Medical Center, were reviewed, and nine patients treated with alendronate for at least 1 year were identified. Patients were excluded from analysis if they had evidence of osteomalacia or if baseline and follow-up BMD results on the same dual-energy x-ray absorptiometry (DEXA) densitometer, at least 10 months apart, were not available. DEXA BMD results at the lumbar spine and hip, before and after at least 10 months of alendronate treatment, were analyzed for significant differences. Patients were also receiving calcium supplementation (1,000 to 1,500 mg/day), and all but one patient received vitamin D (400 to 800 U/day). Lumbar spine BMD increased by 6.4 +/- 1.8% per year with alendronate treatment (P = 0.008). A mean absolute gain of 0.052 +/- 0.010 g/cm 2 (P = 0.005) in lumbar spine BMD was noted for the entire study group (N = 9), after a mean duration of treatment of 14 +/- 1 months. The mean lumbar spine BMD Z score improved by 0.40 +/- 0.09 (P = 0.002) with alendronate therapy. The femoral neck BMD also increased by 4.5 +/- 1.4% per year with alendronate treatment (P = 0.013). The mean absolute gain in femoral neck BMD was 0.028 +/- 0.009 g/cm 2 (P = 0.013) for the study group (N = 9) after 14 +/- 1 months of therapy. The mean femoral neck BMD Z score improved 0.30 +/- 0.08 (P = 0.005) with treatment. BMD gains at the greater trochanter of 3.2 +/- 1.5% per year (P = 0.067) and at Ward's triangle of 9.1 +/- 4.2% per year (P = 0.061) were not statistically significant. Two patients discontinued alendronate treatment after 1 year because of epigastric or retrosternal pain. Oral alendronate treatment, given in combination with calcium supplementation and physiologic doses of vitamin D, resulted in significant improvements in lumbar spine and femoral neck BMD after a 14-month period in this small group of men with osteoporosis. Although controlled, prospective trials involving larger numbers of male patients with fracture incidence data are needed before definitive conclusions can be made, alendronate treatment seems to be effective in improving BMD in men with osteoporosis, similar to its efficacy in women.