Clinical trial NCT00920075: Alendronate in Juvenile Osteoporosis
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Juvenile Osteoporosis
Low Bone Density
Fractures
Keywords: Juvenile Osteoporosis
Bone Mineral Density
Fosamax
Dual Energy X-Ray Absorptiometry
Fracture
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: FDA Office of Orphan Products Development
name: Merck Sharp & Dohme LLC
First posted: 2009-06-15
Enrollment: 11
Sex: ALL
Minimum age (years): 8
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Available male and female children who have participated and Completed in our earlier open label or double blind clinical trial.

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 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 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.

Primary outcomes:
measure: Bone Mineral Density (BMD) of the Lumbar Spine (Participants With Percentage Increase).
timeFrame: Post study (1-6 yrs), one clinical visit
Secondary outcomes:
measure: Bone Mineral Density (BMD) of the Hip (Participants With Percentage Increase).
timeFrame: Post study (1-6 years), one clincial visit
measure: Number of Participants With Fracture
timeFrame: Post study (1-6 years), one clinical visit
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Deborah A Bowlby, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Key LL Jr, Ries W, Madyastha P, Reed F. Juvenile osteoporosis: recognizing the risk. J Pediatr Endocrinol Metab. 2003 May;16 Suppl 3:683-6.