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Sponsored by: |
University of California, San Francisco |
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Information provided by: | University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT00683163 |
This study will test in several innovative ways, several different combinations of PTH and oral monthly ibandronate for the treatment of osteoporosis in postmenopausal women. The intension is to provide other options for treatment than the current standard 2 year course of drug therapy. These options may lead to treatment where the two years of therapy are spread over several years.
Condition | Intervention | Phase |
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Osteoporosis |
Drug: PTH 1-84 Drug: Ibandronate |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study |
Official Title: | PTH & Ibandronate Combination Study (PICS): Optimizing the Use of PTH With Boniva (Pilot Randomized Controlled Trial) |
Estimated Enrollment: | 40 |
Study Start Date: | May 2008 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A.: Active Comparator
Group A will receive 6 months of monthly Ibandronate, plus daily PTH 1-84,100 μg; followed by 18 months of Ibandronate only.
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Drug: PTH 1-84 Drug: Ibandronate |
B: Active Comparator
Group B will receive 3 months of daily PTH 1-84,100 μg; followed by 9 months of monthly Ibandronate in year 1. In year 2, the group will receive another 3 months of daily PTH 1-84,100 μg; followed by 9 months of monthly Ibandronate.
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Drug: PTH 1-84 Drug: Ibandronate |
This randomized double-blind clinical trial for the treatment of postmenopausal osteoporosis will be conducted and coordinated by study investigators who also participated in the investigator-initiated PaTH study. Final data analysis will compare the results from this trial with those from the PaTH study. In the PaTH study, 238 women between 55 and 85 years of age were randomized to receive either:
In the PICS 40 postmenopausal women between the ages of 55 to 75 years of age with osteoporosis who meet the inclusion/exclusion criteria,will be randomized to the following 2 treatment groups. Group A will received 6 months of monthly Ibandronate, plus daily PTH 1-84,100 μg; followed by 18 months of Ibandronate only. Group B will received 3 months of daily PTH 1-84,100 μg; followed by 9 months of monthly Ibandronate, over 2 years. Calcium (400-650 mg) and Vitamin D (400 IU) supplements will be provided to all participants.
The primary objective is to determine if, at 3 months, the women treated with the concurrent combination of PTH and ibandronate (Group A) show a significant increase in bone marker formation compared to baseline (unlike the combination PTH/alendronate-treated women in PaTH). This will be accessed by examining the change in the markers P1NP, BSAP and serum CTX.
As a secondary objective, we will compare the trabecular spine BMD measures of those treated with concurrent PTH/Ibandronate (Group A) to those who received 3 months of PTH followed by Ibandronate(Group B). Another secondary objective will be to compare changes between groups in trabecular bone and DXA spine BMD after 2 years of treatment.
Changes to the fat content of the vertebrae during a course of PTH therapy will be examined using MRI spinal spectroscopy. Crosstabulation of these changes against changes in trabecular BMD, should indicate an effect on measurements. As well, the effect of a second three-month course of PTH therapy in Group B is of major interest.
Ages Eligible for Study: | 55 Years to 75 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Trisha Hue, MPH, PhD (cand.) | 415-514-8000 | thue@psg.ucsf.edu |
United States, California | |
University of California, San Francisco | Recruiting |
San Francisco, California, United States, 94115 | |
Contact: Leyla Herrera 415-353-9720 |
Principal Investigator: | Dennis M. Black, PhD | University of California, San Francisco |
Responsible Party: | University of California, San Francisco Coordinating Center ( Dennis Black, PhD ) |
Study ID Numbers: | PICS001 |
Study First Received: | May 20, 2008 |
Last Updated: | May 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00683163 |
Health Authority: | United States: Food and Drug Administration |
Combination of PTH and ibandronate Bone marker formation Postmenopausal Trabecular spine BMD |
Ibandronic acid Musculoskeletal Diseases Osteoporosis Bone Diseases, Metabolic Bone Diseases |
Physiological Effects of Drugs Bone Density Conservation Agents Pharmacologic Actions |