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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00018447
Other study ID # ENDO-022-98S
Secondary ID
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
Est. primary completion date
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


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, 

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