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Home > "A" Clinical Trials Conditions > Alendronate and/or Parathyroid Hormone for Osteoporosis  Alendronate and/or Parathyroid Hormone for Osteoporosis
Alendronate and/or Parathyroid Hormone for Osteoporosis
For Condition: Osteoporosis
Status: No longer recruiting
Sponsor(s): National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) ,
Synopsis: This study looks at the effects of two medications, alendronate and parathyroid hormone, on bone mass and on bone formation and bone breakdown in women with osteoporosis. We will randomly select postmenopausal women who have osteoporosis to receive laboratory-produced human parathyroid hormone (hPTH), or alendronate, or both for 2.5 years. Study participants will return to the study center periodically to have their bone mass measured and to give blood and urine samples for tests of bone formation and breakdown and for other laboratory tests.
Details: This is a randomized, prospective, open-label study in which osteoporotic postmenopausal women self-administer synthetic hPTH-(1-34), alendronate, or both, every day for 2.5 years. Participants initially come to Massachusetts General Hospital once a month, and subsequently once every 3-6 months, for measurements of serum and urine indices of bone formation and resorption, serum and urine toxicity tests, and DXA measurements of bone mass. One-third of the participants take hPTH-(1-34) daily, one-third take alendronate once daily, and one-third take both daily.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 45 Years/85 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Lumbar spine or hip BMD T-score < or = minus 2.0 - Postmenopausal at least 5 years - Must be fully ambulatory - Must be able to give informed consent Exclusion Criteria: - No concurrent illnesses that cause bone loss - No recent drug treatment for osteoporosis - No recent fracture
Total Enrollment: 108
Location and Contact Information:
Overall Study Official:
RobertNeer, Principal Investigator, Massachusetts General Hospital
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Additional Information:
Study ID Numbers: NIAMS-023; P50 AR44855
Study Start Date: August 1999
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000400
Other Osteoporosis Studies:
1. Osteoporosis Prevention in Preadolescent Girls
2. Osteoporosis Prevention: Changes to Exercise and Diet in Children
3. Effect of Androgen Suppression on Bone Loss in Patients With or Without Bone Metastases Secondary to Prostate Cancer
4. Goserelin in Preventing Ovarian Failure in Women Receiving Adjuvant Chemotherapy for Breast Cancer
5. Low-Dose Hormone Replacement Therapy and Alendronate for Osteoporosis
Related Studies:
Other Osteoporosis Clinical Trials
Other Massachusetts Clinical Trials
Other Boston Clinical Trials
Alendronate and/or Parathyroid Hormone for Osteoporosis
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