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Alendronate in Juvenile Osteoporosis

Information source: Medical University of South Carolina
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Juvenile Osteoporosis; Low Bone Density; Fractures

Intervention: Alendronate (Fosamax) (Drug)

Phase: N/A

Status: Completed

Sponsored by: Medical University of South Carolina

Official(s) and/or principal investigator(s):
Deborah A Bowlby, M.D., Principal Investigator, Affiliation: Medical University of South Carolina


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.

Clinical Details

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.

Study design: N/A

Primary outcome: Bone Mineral Density (BMD) of the Lumbar Spine (Participants With Percentage Increase).

Secondary outcome:

Bone Mineral Density (BMD) of the Hip (Participants With Percentage Increase).

Number of Participants With Fracture

Detailed description: 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.


Minimum age: 8 Years. Maximum age: 21 Years. Gender(s): Both.


Inclusion Criteria:

- Participated in our earlier clinical study;

- Completed the earlier open label or double blind study;

- Availability to participate in the post study;

- Male and female children who have earlier participated in our clinical trial; AND

- Parental consent (and patient assent after age 12 years) to participate in the

study. Participant's consent for those who have completed 18 years of age and above at the time of clinic visit. Exclusion Criteria:

- Not participated in our earlier clinical study;

- Not completed our earlier trials; OR

- Pregnancy.

Locations and Contacts

Medical University of South Carolina, Charleston, South Carolina 29425, United States
Additional Information

Starting date: July 2009
Last updated: November 9, 2010

Page last updated: August 20, 2015

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