Clinical Trial: Alendronate in Juvenile Osteoporosis

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Phase II Study of Alendronate Sodium in Juvenile Osteoporosis (IND# 60,017)-Post Study Evaluation of Participants From Phase IIa and Phase IIb Clinical Study.

Brief Summary: The investigators earlier have shown that treatment of patients with juvenile osteoporosis with alendronate (Fosamax) for 12 months increased the bone density without side effects. In an open label study (10 patients) and double blind, crossover study (11 patients alendronate and 11 patients placebo), the investigators have further observed that alendronate increased the bone density significantly where as placebo (calcium and vitamin D) increased only minimally. These trials were completed. Thus, a post study is designed to evaluate the current status of the bone density and fractures after the patients discontinued the alendronate treatment. No treatment is involved.

Detailed Summary: With the availability of Dual Energy X-ray Absorptiometry (DXA), juvenile osteoporosis has been recognized and diagnosed in recent years. The disease results from either diminished bone formation or increased bone removal (resorption) resulting in low bone density and fractures. No specific drug therapy has been recommended for juvenile osteoporosis. In an open label study, we earlier have shown that alendronate treatment (10 patients) for 12 months increased bone density without side effects. Subsequently, in a double blind, crossover study, we have further confirmed that alendronate treatment (11 patients) increased bone density significantly whereas, placebo (11 patients with calcium and vitamin D), increased the bone density only minimally. There were no side effects. These patients were treated with alendronate only for 12 months and the clinical trials have been completed. We therefore, have designed a post study to evaluate the current status of the bone density and fracture history in the above participants after the discontinuation (1-6 years) of alendronate treatment. Available participants, who have completed the earlier study, will be scheduled for a one time clinic visit. Measurements include DXA bone density measurement of spine and hip, urinalysis and blood work. No treatment is involved.
Sponsor: Medical University of South Carolina

Current Primary Outcome: Bone Mineral Density (BMD) of the Lumbar Spine (Participants With Percentage Increase). [ Time Frame: Post study (1-6 yrs), one clinical visit ]

Participants who earlier completed in our open labeled or double blind study of alendronate treatment for juvenile osteoporosis, were invited for one clinical visit. Bone density of spine was measured by DXA scan.


Original Primary Outcome: Bone Mineral Density (BMD) of the Lumbar Spine and Hip. [ Time Frame: Post study ]

Current Secondary Outcome:

  • Bone Mineral Density (BMD) of the Hip (Participants With Percentage Increase). [ Time Frame: Post study (1-6 years), one clincial visit ]
    Participants who earlier completed in our open labeled or double blind study of alendronate treatment for juvenile osteoporosis, were invited for one clinical visit. Bone density of hip was measured by DXA scan.
  • Number of Participants With Fracture [ Time Frame: Post study (1-6 years), one clinical visit ]
    Participants who earlier completed in our open labeled or double blind study of alendronate treatment for juvenile osteoporosis, were invited for one clinical visit. Their bone densities of spine and hip were measured by DXA scan. During this visit, their fracture history was obtained.


Original Secondary Outcome: Fractures, changes in biochemical markers [ Time Frame: Post study ]

Information By: Medical University of South Carolina

Dates:
Date Received: June 11, 2009
Date Started: July 2009
Date Completion:
Last Updated: November 9, 2010
Last Verified: November 2010