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Combination Osteogenic Therapy in Established Osteoporosis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00018447
First Posted: July 5, 2001
Last Update Posted: January 21, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
VA Office of Research and Development
  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: None (Open Label)
Primary Purpose: Treatment
Official Title: Combination Osteogenic Therapy in Established Osteoporosis

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

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

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 80 Years   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00018447


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

ClinicalTrials.gov Identifier: NCT00018447     History of Changes
Other Study ID Numbers: ENDO-022-98S
First Submitted: July 3, 2001
First Posted: July 5, 2001
Last Update Posted: January 21, 2009
Last Verified: December 2004

Keywords provided by VA Office of Research and Development:
osteoporosis

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