Combination Osteogenic Therapy in Established Osteoporosis

Osteoporosis, Post-Menopausal Clinical Trial

Official title:

Combination Osteogenic Therapy in Established Osteoporosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00018447
• Other study ID #: ENDO-022-98S
• Status: Completed
• Phase: Phase 2
• First received: July 3, 2001
• Last updated: January 20, 2009
• Start date: November 1998
• Est. completion date: October 2003

Study information

• Verified date: December 2004
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: October 2003
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 60 Years to 80 Years

Eligibility

• Female, aged 60-80,

• Postmenopausal greater than or equal to 5 years,

• BMD -2.5 to -4.0 at lumbar spine or femoral neck and one standard deviation below young adult mean in the other site, or -2.0 with fracture.

• Vertebral fracture 0-1.

Exclusion Criteria:

• More than 1 vertebral fracture in lumbar spine or more than 4 fracture in the T-L spine.

• Weight less than 45 kg or more than 80 kg, or more than 25% above ideal body weight.

• Present cardiac disease present.

• Diseases or conditions known to affect bone metabolism.

• Therapies with drugs that affect bone metabolism within 6 months.

• Fluoride or Biophosphonates at any time.

Study Design

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis, Post-Menopausal
• Osteoporosis, Postmenopausal

Intervention

Drug:
• PTH 1-34

• MFPSR-fluoride

Locations

Country	Name	City	State
United States	Jerry L. Pettis Memorial Veterans Medical Center	Loma Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States,