Combination Osteogenic Therapy in Established Osteoporosis - Tabular View

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Combination Osteogenic Therapy in Established Osteoporosis

This study has been completed.

Study NCT00018447. Last updated on June 11, 2007. Information provided by Department of Veterans Affairs

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields
Brief Title ^†	Combination Osteogenic Therapy in Established Osteoporosis
Official Title ^†	Combination Osteogenic Therapy in Established Osteoporosis
Brief 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.
Study Phase	Phase II
Study Type ^†	Interventional
Study Design ^†	Treatment, Randomized, Open Label
Primary Outcome Measure ^†
Secondary Outcome Measure ^†
Condition ^†	Osteoporosis, Post-Menopausal
Intervention ^†	Drug: PTH 1-34 Drug: MFPSR-fluoride
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Recruitment Information Fields
Recruitment Status ^†	Completed
Enrollment ^†
Start Date ^†	November 1998
Completion Date	October 2003
Eligibility 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.
Gender	Female
Ages	60 Years to 80 Years
Accepts Healthy Volunteers	Yes
Contacts ^††
Location Countries ^†	United States

Administrative Information Fields
NCT ID ^†	NCT00018447
Organization ID	ENDO-022-98S
Secondary IDs ^††
Study Sponsor ^†	Department of Veterans Affairs
Collaborators ^††
Investigators ^†
Information Provided By	Department of Veterans Affairs
Verification Date	December 2004
First Received Date ^†	July 3, 2001
Last Updated Date	June 11, 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.