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Home > "E" Clinical Trials Conditions > Effects of Parathyroid Hormone in Men with Osteoporosis  Effects of Parathyroid Hormone in Men with Osteoporosis
Effects of Parathyroid Hormone in Men with Osteoporosis
For Condition: Osteoporosis
Status: No longer recruiting
Sponsor(s): National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) ,
Synopsis: Alendronate is a drug that blocks or reduces bone loss, while parathyroid hormone (PTH) stimulates the formation of new bone. The purpose of this study is to compare the bone-building effects of PTH alone, alendronate alone, and both PTH and alendronate in men with osteoporosis over a two-and-a-half year period.
Details: Osteoporosis causes bones to weaken and break more easily. Alendronate is used to treat or prevent osteoporosis. PTH is a protein hormone that increases the calcium and phosphorus release from bone, leading to formation of new bone. This study will examine the changes in bone density measured at multiple places in the skeleton and changes in chemicals in the body that indicate bone breakdown and bone formation. The study will indicate whether some breakdown of bone is required for PTH to have an overall bone-building effect in men. Participants will be randomly assigned to receive PTH alone by daily injection under the skin, alendronate alone taken by mouth, or both PTH and alendronate. The study will last 2.5 years. All participants will receive some form of treatment for osteoporosis. Blood, urine, and bone density tests will be performed at 6-month intervals. During the first 6 months, participants will come in for additional study visits. Participants who complete the initial 2.5 years of their assigned treatment will be eligible for a 12 month extension to monitor bone density and bone turnover after PTH is stopped. Participants who were receiving alendronate will continue taking alendronate. The goal of this extension is to determine what happens to bone density and turnover after PTH is stopped and whether alendronate is needed to prevent loss of PTH-induced bone gain. Participants who complete the 12 month extension while on their assigned treatment will be eligible for a second 12 month extension in which all participants receive PTH therapy. Participants who have been receiving alendronate continue taking alendronate. The goal of the second extension is to determine if responsiveness to PTH is enhanced by a 12 month suspension of PTH treatment.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 46 Years/85 Years
Genders: Male
Protocol Entry Criteria: Inclusion Criteria: - Bone density of the spine or femoral neck two standard deviations below the mean of young adult men - Normal renal and liver function tests, normal serum testosterone level, normal vitamin D and PTH levels Exclusion Criteria: - Significant cardiac, renal, hepatic, or malignant disease. - Disorders (e.g., Paget's disease, hyperthyroidism, hyperparathyroidism) or drugs (e.g., steroids, anticonvulsants, lithium, bisphosphonates, calcitonin, fluoride) known to affect bone metabolism - Active peptic ulcer disease or severe reflux
Total Enrollment: 81
Location and Contact Information:
Overall Study Official:
JoelFinkelstein, Principal Investigator, Massachusetts General Hospital
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Additional Information:
Study ID Numbers: NIAMS-015; P50 AR44855
Study Start Date: September 1999
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000427
Other Osteoporosis Studies:
1. Low-Dose Hormone Replacement Therapy and Alendronate for Osteoporosis
2. Therapeutic Touch for Wrist Fractures in Postmenopausal Women
3. Osteoporosis Prevention in Preadolescent Girls
4. Randomized Study of Alendronate in Adult Patients With Cystic Fibrosis Related Osteoporosis
5. Treatment of Calcium Deficiency in Young Women
Related Studies:
Other Osteoporosis Clinical Trials
Other Massachusetts Clinical Trials
Other Boston Clinical Trials
Effects of Parathyroid Hormone in Men with Osteoporosis
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