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