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| Descriptive Information Fields | |
| Brief Title † | Combination Osteogenic Therapy in Established Osteoporosis |
| Official Title † | Combination Osteogenic Therapy in Established Osteoporosis |
| Brief Summary | This study is designed to determine if combining parathyroid (PTH 1-34) with fluoride (MFPSR) therapy in a cyclic treatment regimen will: (1) produce a greater increase in bone density of the spine than would be produced by either treatment alone; (2) prevent the resistance (i.e., decreased bone formation and no further increase in bone density) that is observed within 18-24 months of PTH therapy; (3) eliminate the calcium deficiency and osteomalacia that can occur with fluoride; (4) prevent excessive bone fluoride content; and (5) result in an increase in bone density which is maintained after treatment is discontinued. |
| Detailed Description | This is a 3-yr, single center, open label, active controlled, randomized study of approximately 99 postmenopausal females with osteoporosis of spine or femoral neck. Patients will be assigned to 1 of 3 groups: 1) PTH 1-34; 2) Fluoride; 3) PTH and fluoride. The treatment period is 3 years with 3-month cycles of therapy. PTH will be administered subcutaneously by injection 600 units daily for 28 days the first month of each 3-month cycle. Fluoride will be administered orally one 76mg tablet twice daily (providing 20 mg fluoride/day), during the last 2 months of each cycle. Calcium will be provided 800mg/day during month 1 and 1500-2000mg for months 2 and 3 of each cycle. |
| Study Phase | Phase II |
| Study Type † | Interventional |
| Study Design † | Treatment, Randomized, Open Label |
| Primary Outcome Measure † | |
| Secondary Outcome Measure † | |
| Condition † | Osteoporosis, Post-Menopausal |
| Intervention † | Drug: PTH 1-34 Drug: MFPSR-fluoride |
| MEDLINE PMIDs | |
| Links | |
| Recruitment Information Fields | |
| Recruitment Status † | Completed |
| Enrollment † | |
| Start Date † | November 1998 |
| Completion Date | October 2003 |
| Eligibility Criteria † |
Exclusion Criteria:
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| Gender | Female |
| Ages | 60 Years to 80 Years |
| Accepts Healthy Volunteers | Yes |
| Contacts †† | |
| Location Countries † | United States |
| Administrative Information Fields | |
| NCT ID † | NCT00018447 |
| Organization ID | ENDO-022-98S |
| Secondary IDs †† | |
| Study Sponsor † | Department of Veterans Affairs |
| Collaborators †† | |
| Investigators † | |
| Information Provided By | Department of Veterans Affairs |
| Verification Date | December 2004 |
| First Received Date † | July 3, 2001 |
| Last Updated Date | June 11, 2007 |