NCT00018447

Combination Osteogenic Therapy in Established Osteoporosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: US Department of Veterans Affairs · Federal
• Sex: Female
• Age: 60 Years – 80 Years
• Healthy volunteers: Accepted

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.

Conditions

• Osteoporosis, Post-Menopausal

Interventions

Type	Name	Description
DRUG	PTH 1-34
DRUG	MFPSR-fluoride

Timeline

• Start date: 1998-11-01
• Completion: 2003-10-01
• First posted: 2001-07-05
• Last updated: 2009-01-21

Locations

1 site across 1 country: United States