Review of the safety and efficacy of risedronate for the treatment of male osteoporosis

 


Estimation of the prevalence of low bone density in canadian women and men using a population-specific DXA reference standard: Table 1 Summary of randomized controlled trials of risedronate for the treatment of male osteoporosis. Rakip entered his first international tournament at the FIFA U World Cup in the United Arab Emirates where Sweden won a bronze medal, he scored his first international goal against Honduras in the quarter final.

Osteoporosis in men


Risedronate was well tolerated in men, with a similar incidence of upper gastrointestinal adverse events in the placebo and treatment groups. They concluded that daily treatment with risedronate increases bone density and decreases vertebral fracture risk within 1 year in men receiving corticosteroid therapy.

Risedronate has been studied in a number of other conditions including post-stroke Sato et al , hyperthyroidism Majima et al , inflammatory bowel disease Henderson et al , transplantation Tauchmanova et al , leprosy Kanaji et al , and stress fractures in infantry recruits Milgrom et al There is a high incidence of hip fractures in patients after hemiplegic stroke.

Bone mineral density is decreased on the hemiplegic side in patients after stroke, correlating with the immobilization-induced bone resorption, the degree of paralysis, and hypovitaminosis D. Sato et al evaluated the effectiveness of risedronate on osteoporosis and the risk of hip fractures in men 65 years or older after stroke. They conducted an month, randomized, double-blind trial of male patients 65 years or older who were post-stroke, with receiving a daily dose of 2.

The mean age in both groups was There were no significant differences between the placebo group and risedronate group in Barthel Index, degree of hemiplegia, number of fallers, type of stroke, BMD, or biochemical indices of bone metabolism.

Although the values of BMD on both hemiplegic and nonhemiplegic sides were within the reference range compared with the elderly general Japanese population, BMD on the hemiplegic side was significantly reduced compared with that of the nonhemiplegic side. Compared with the reference range of the elderly general Japanese population, both groups of patients had high levels of serum ionized calcium and urinary D-Pyr and low serum concentrations of PTH, OHD, and 1, OH 2 D at baseline.

Serum OHD was outside of the reference range in both groups: During the study, a total of falls occurred in the former group and in the latter group, or 4. The number of falls among fallers ranged from 1 to 12 in both groups. Ten patients sustained hip fractures in the placebo group, and 2 hip fractures occurred in the risedronate group.

The relative risk of a hip fracture was reduced with risedronate to 0. Bone mineral density increased by 2. Urinary deoxypyridinoline, a bone resorption marker, decreased by They concluded that treatment with risedronate increases bone mineral density and reduces hip fractures in elderly men who are post-stroke Sato et al It has been well established that hyperthyroidism leads to diminished BMD, and that a previous history of hyperthyroidism remains a risk factor for fractures.

However, little is known about how to manage the reduction in BMD caused by hyperthyroidism. They were randomly divided into two groups by therapeutic regimen. Fourteen patients were treated with an antithyroid drug and risedronate and the control group consisted of 13 patients treated with the same antithyroid drug only. The mean age and BMI was BMD at the lumber spine, femoral neck, and distal radius were measured at baseline, and at 6 and 12 months after the trial.

Bone-specific alkaline phosphatase and urinary N-terminal telopeptide of type I collagen normalized by creatinine were significantly more reduced in the risedronate treated group than in the control group after both 6 and 12 months.

The percentage increases in BMD at the lumbar spine femoral neck and distal radius at 1 year were 6. Low bone density and fractures are common in patients with inflammatory bowel disease IBD. Henderson et al conducted a study to determine whether risedronate is safe and effective in preserving bone mass compared with calcium alone in IBD patients with low bone mass.

Patients were randomized to 12 months of therapy with risedronate 5 mg or placebo. All received a mg calcium supplement. Bone density using dual energy x-ray absorptiometry was performed at baseline and at 12 months. Disease activity, use of corticosteroid, and adverse events were noted. Forty-eight patients completed the trial. Compared with the placebo group, risedronate resulted in a 2.

IBD diagnosis, gender, therapy, and disease status had no effect on the results. There were no significant differences in the adverse events. These data suggest that risedronate is a safe and effective therapy to improve bone mass in these patients Henderson et al In this prospective randomized study risedronate was evaluated in patients who had undergone allogeneic stem cell transplant SCT for hematological malignancies Tauchmanova et al The duration of treatment was 12 months.

After 12 months, lumbar BMD increased 5. They concluded that treatment with risedronate for 12 months increased BMD significantly at the lumbar spine and prevented further bone loss at the femoral neck in long-term survivors after allogeneic stem cell transplantation. Kanaji et al evaluated the therapeutic effect of risedronate in male osteoporotic patients with leprosy. Twenty-three male patients with leprosy, 63—87 years of age, were randomly divided into two groups, risedronate, 2.

There were no significant differences in age, body mass index, BMD, or urinary NTX levels at baseline between the two groups. They showed that oral administration of risedronate prevented vertebral fractures. There were a mean of 0. Increased lumbar BMD and significant reductions of bone turnover as measured by urinary NTX levels were seen with risedronate compared with placebo. These findings suggest that oral administration of risedronate contributes to the prevention of vertebral fractures by suppressing bone resorption and increasing in lumbar BMD in the elderly male patients with leprosy.

A randomized, double-blind, placebo controlled trial of new infantry recruits known to be at high risk for stress fracture was conducted Milgrom et al Recruits were given a loading dose of 30 mg of risedronate or placebo daily for 10 doses during the first 2 weeks of basic training and then a once a week maintenance dose for the following 12 weeks.

Recruits were monitored by biweekly orthopedic examinations during 15 weeks of basic training for stress fractures. Bone scans for suspected tibial and femoral stress fractures and radiographs for suspected metatarsal stress fractures were used to verify stress fracture occurrence. No statistically significant difference in the tibial, femoral, metatarsal, or total stress fracture incidence between the treatment group and the placebo group was seen and it was concluded that prophylactic treatment with risedronate in a training population at high risk for stress fracture using a maintenance dosage for the treatment of osteoporosis does not lower stress fracture risk.

Osteoporosis in men is a significant cause of morbidity and mortality. Risedronate is effective in increasing BMD in primary and corticosteroid-induced osteoporosis in men and more importantly the prevention of vertebral fractures within the first year of therapy in corticosteroid-treated men.

Risedronate is also effective in the prevention of hip fractures post stroke and vertebral fractures in those with leprosy. Risedronate was ineffective in the prevention of stress fractures in infantry recruits.

National Center for Biotechnology Information , U. Journal List Clin Interv Aging v. Raja Bobba 1 and Jonathan D Adachi 2. Raja Bobba 1 Department of Medicine, St. Author information Copyright and License information Disclaimer. This article has been cited by other articles in PMC.

Abstract Osteoporosis in men is an increasingly recognized problem with associated fracture morbidity and mortality. Osteoporosis in men Osteoporosis is increasingly recognized in men as a condition that is associated with significant morbidity and mortality. Risedronate Risedronate [1-hydroxy 3-pyridinyl ethylidene bisphosphonic acid monosodium salt], Cincinnati , is a potent pyridinyl bisphosphonate that has been shown to decreases the risk of vertebral and nonvertebral fractures in postmenopausal women with osteoporosis Harris et al ; Reginster et al ; McClung et al Table 1 Summary of randomized controlled trials of risedronate for the treatment of male osteoporosis.

Open in a separate window. Primary osteoporosis Boonen et al recently reported in abstract from, a 2-year, double-blind, randomized, placebo-controlled, parallel group, multicenter study to determine the efficacy and safety of risedronate 35 mg once a week Boonen et al , compared with placebo in men with osteoporosis. Corticosteroid-induced bone loss Limited information is available on the effect of bisphosphonates in men receiving corticosteroid therapy.

Risedronate in the treatment of corticosteroid-induced osteoporosis. Risedronate in the prevention of corticosteroid-induced osteoporosis. Other conditions Risedronate has been studied in a number of other conditions including post-stroke Sato et al , hyperthyroidism Majima et al , inflammatory bowel disease Henderson et al , transplantation Tauchmanova et al , leprosy Kanaji et al , and stress fractures in infantry recruits Milgrom et al Post-stroke There is a high incidence of hip fractures in patients after hemiplegic stroke.

Hyperthyroidism It has been well established that hyperthyroidism leads to diminished BMD, and that a previous history of hyperthyroidism remains a risk factor for fractures.

Inflammatory bowel disease Low bone density and fractures are common in patients with inflammatory bowel disease IBD. Transplantation In this prospective randomized study risedronate was evaluated in patients who had undergone allogeneic stem cell transplant SCT for hematological malignancies Tauchmanova et al Leprosy Kanaji et al evaluated the therapeutic effect of risedronate in male osteoporotic patients with leprosy. Stress fractures A randomized, double-blind, placebo controlled trial of new infantry recruits known to be at high risk for stress fracture was conducted Milgrom et al Summary Osteoporosis in men is a significant cause of morbidity and mortality.

Risedronate shown to be safe and effective in men with osteoporosis in a 2-year, double-blind, randomized, placebo-controlled, multicentre study. Risedronate therapy prevents corticosteroid-induced bone loss: Pharmacotherapy of osteoporosis in men. Effects of risedronate treatment on vertebral and nonvertebral fractures in women with postmenopausal osteoporosis: Retrieved 19 February The Swedish Football Association.

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