Combination Osteogenic Therapy in Established Osteoporosis

This study has been completed.
Sponsor:
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00018447
First received: July 3, 2001
Last updated: January 20, 2009
Last verified: December 2004
  Purpose

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.


Condition Intervention Phase
Osteoporosis, Post-Menopausal
Drug: PTH 1-34
Drug: MFPSR-fluoride
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
Official Title: Combination Osteogenic Therapy in Established Osteoporosis

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Study Start Date: November 1998
Estimated Study Completion Date: October 2003
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.

  Eligibility

Ages Eligible for Study:   60 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria
  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00018447

Locations
United States, California
Jerry L. Pettis Memorial Veterans Medical Center
Loma Linda, California, United States, 92357
Sponsors and Collaborators
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00018447     History of Changes
Other Study ID Numbers: ENDO-022-98S
Study First Received: July 3, 2001
Last Updated: January 20, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Department of Veterans Affairs:
osteoporosis

Additional relevant MeSH terms:
Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Fluorides
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014