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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: | NCT00005006 |
This study investigates the effectiveness of parathyroid hormone (PTH) in combination with alendronate, a standard treatment for osteoporosis that blocks or reduces bone loss. We are using alendronate because it may help protect patients against any possible harmful effects of PTH in cortical bone such as the long bones or hip. We are testing two different treatment schedules of PTH-one in which we give PTH daily and one in which we give PTH for 3 out of every 6 months in a cyclical fashion. The entire study is 21 months long; the active treatment period is 18 months with a 6-month followup period.
The main effects we will look for in this study are changes in body chemicals that are signs of bone formation or bone breakdown, and changes in bone density throughout the skeleton. We will randomly assign all study participants, who are women aged 50 and over, to either stay on alendronate alone, receive daily continuous PTH plus alendronate, or receive daily PTH for 3 months out of every 6 for a total of three separate 3-month cycles of PTH plus daily alendronate.
Condition | Intervention | Phase |
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Osteoporosis |
Drug: Parathyroid Hormone Drug: Alendronate Drug: Teriparatide |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Placebo Control, Single Group Assignment, Efficacy Study |
Official Title: | Cyclical vs Daily Continuous PTH in Combination With Alendronate vs Alendronate Alone |
Estimated Enrollment: | 140 |
Study Start Date: | September 1987 |
Study Completion Date: | December 2006 |
Primary Completion Date: | February 2003 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Alendronate alone
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Drug: Alendronate
Alendronate 70mg/week
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2: Active Comparator
Teriparatide daily plus alendronate
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Drug: Alendronate
Alendronate 70mg/week
Drug: Teriparatide
Teriparatide 20mcg/day
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3: Active Comparator
Teriparatide cyclically plus alendronate
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Drug: Parathyroid Hormone
Alendronate 70mg/week; Teriparatide 20mcg/ day
Drug: Alendronate
Alendronate 70mg/week
Drug: Teriparatide
Teriparatide 20mcg/day
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Osteoporosis is a significant disease because it increases the risk of fractures throughout the skeleton, most importantly in the spine and hip regions. The current medications for osteoporosis, which include estrogens, bisphosphonates, raloxifene, and calcitonin, all primarily prevent bone loss, although each may be associated with small bone gains. Another class of drugs, the anabolic drugs, will increase bone formation more substantially, leading to bigger gains in bone mass. One of these, sodium fluoride, clearly increases bone mass but may or may not reduce fracture risk. Another bone-forming agent is human parathyroid hormone (PTH). We and others have demonstrated substantial bone mass gains as well as a reduction in vertebral fracture with the use of PTH administered by daily subcutaneous injection.
The current study seeks to capitalize on the knowledge gleaned about PTH-induced stimulation of bone formation prior to resorption in subjects on antiresorptive therapy such as estrogen or alendronate. In this protocol we have chosen to give PTH by daily subcutaneous injection in the presence of alendronate. We have already shown that with 6 weeks of daily subcutaneous h(1-34)PTH 400 U/day in patients on established alendronate, biochemical indicators of bone formation are substantially increased (30-60 percent), with no stimulation of resorption over this time frame.
We hypothesize that, over 3 months, the combination of PTH plus alendronate will, like the combination of PTH plus hormone replacement therapy, result in increments in bone formation exceeding those of bone resorption. We also theorize that this biochemical profile will be reflected in a greater effect on bone mass than during therapy with alendronate alone, when both formation and resorption are elevated. Furthermore, we believe that the changes over the first 3 months can be repeated over additional discrete 3-months cycles after bone turnover returns to baseline.
Therefore, we plan to study the difference in bone mass and biochemical indicators of bone turnover when, in the presence of established alendronate therapy, we give PTH by daily subcutaneous injection continuously for 15 months (in which bone resorption is elevated substantially for more than half of the time) versus discontinuously in three discrete 3-month cycles (in which bone formation will dramatically exceed bone resorption for the entire treatment period).
The candidates for this study are postmenopausal women who have osteoporosis defined by either bone density and/or prior osteoporotic fracture occurrence and, in addition, have used alendronate for at least 18 months prior to entering into the study. Patients must be over the age of 50.
The entire study is 21 months long; the active treatment period is 18 months with a 6- month followup period. The primary outcomes in this study are biochemistry and bone density throughout the skeleton. We will randomly assign all participants to either remain on alendronate alone, receive daily continuous PTH plus alendronate, or receive daily PTH for 3 months out of every 6, for a total of three separate 3-month cycles of PTH, both with PTH given in addition to daily or weekly alendronate.
Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, New York | |
Helen Hayes Hospital, Clinical Research Center | |
West Haverstraw, New York, United States, 10993 |
Principal Investigator: | Robert Lindsay, MD | Helen Hayes Hospital |
Principal Investigator: | Felicia Cosman, MD | Helen Hayes Hospital |
Responsible Party: | Health Research Inc ( Michael Nazarko ) |
Study ID Numbers: | P50 AR39191, NIAMS-019, Subproject 5 |
Study First Received: | March 24, 2000 |
Last Updated: | March 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00005006 |
Health Authority: | United States: Food and Drug Administration; United States: Federal Government |
Anabolic agent hPTH PTH Parathyroid hormone Bone mass |
Bone turnover Bone formation Alendronate Osteoporosis Cyclical therapy |
Musculoskeletal Diseases Teriparatide Alendronate |
Osteoporosis Bone Diseases, Metabolic Bone Diseases |
Physiological Effects of Drugs Bone Density Conservation Agents Pharmacologic Actions |