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Sponsored by: |
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
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Information provided by: | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
ClinicalTrials.gov Identifier: | NCT00005005 |
This 2-year study will test the effectiveness of combining parathyroid hormone (PTH) and alendronate for treating osteoporosis in postmenopausal women. Alendronate is a drug used to treat osteoporosis and primarily prevents bone loss, whereas PTH increases bone formation. We will treat the study participants either with PTH and alendronate, alendronate alone, or PTH alone. We will determine the effects of these treatments by looking for changes in bone mineral density in the hip and spine.
Condition | Intervention | Phase |
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Osteoporosis |
Drug: PTH Drug: Alendronate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Clinical Trial of Parathyroid Hormone (PTH) and Alendronate in Combination in the Treatment of Osteoporosis |
Enrollment: | 238 |
Study Start Date: | October 1999 |
Study Completion Date: | November 2007 |
Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Participants will receive PTH for 1 year followed by alendronate for 1 year.
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Drug: PTH Drug: Alendronate |
2: Experimental
Participants will receive PTH and alendronate for 1 year followed by alendronate for 1 year.
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Drug: PTH Drug: Alendronate |
3: Experimental
Participants will receive alendronate for 2 years.
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Drug: Alendronate |
4: Active Comparator
Participants will receive PTH for 1 year followed by placebo for 1 year.
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Drug: PTH |
The PaTH study is a 2-year, multicenter, double-blind, placebo-controlled trial to test the efficacy of combining hPTH (1-84) and alendronate for treating osteoporosis in postmenopausal women.
238 women were randomized between 55 and 85 years of age to receive either: (1) PTH for 1 year followed by alendronate for 1 year; (2) PTH and alendronate for 1 year followed by alendronate for 1 year; (3) alendronate for 2 years; or (4) PTH for 1 year followed by placebo for 1 year. The primary endpoints are changes in bone mineral density at several sites and changes in biochemical markers.
In addition, we will assess specific biochemical markers of bone turnover (e.g., osteocalcin, deoxypridinoline, N-telopeptide, bone-specific alkaline phosphatase and bone sialoprotein) to determine if they can predict the skeletal response to combination therapy. We will also determine whether PTH positively affects ultrasound measurements in the calcaneus.
Ages Eligible for Study: | 55 Years to 85 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Maine | |
Maine Center for Osteoporosis | |
Bangor, Maine, United States, 04401 | |
United States, Minnesota | |
University of Minnesota | |
Minneapolis, Minnesota, United States, 55415 | |
United States, New York | |
Columbia University | |
New York, New York, United States, 10032 | |
United States, Pennsylvania | |
University of Pittsburgh Medical Center | |
Pittsburgh, Pennsylvania, United States, 15213 |
Principal Investigator: | Dennis Black, PhD | University of California, San Francisco |
Responsible Party: | University of California San Francisco ( Dr. Dennis Black ) |
Study ID Numbers: | N01 AR92245, NIAMS-045 |
Study First Received: | March 24, 2000 |
Last Updated: | September 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00005005 History of Changes |
Health Authority: | United States: Food and Drug Administration |
PTH Alendronate Parathyroid hormone Osteoporosis Postmenopausal |
Musculoskeletal Diseases Alendronate Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Osteoporosis |
Bone Density Conservation Agents Bone Diseases, Metabolic Hormones Bone Diseases |
Musculoskeletal Diseases Alendronate Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Osteoporosis |
Bone Density Conservation Agents Bone Diseases, Metabolic Hormones Bone Diseases Pharmacologic Actions |