N/A
Completed N=11
Alendronate in Juvenile Osteoporosis
Juvenile Osteoporosis · Low Bone Density · Fracture
Source: ClinicalTrials.gov NCT00920075 ↗
Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Dec 2010
Primary outcomePrimary: Bone Mineral Density (BMD) of the Lumbar Spine (Participants With Percentage Increase). — 11 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Bone Mineral Density (BMD) of the Lumbar Spine (Participants With Percentage Increase). |
11 | — |
| SECONDARY Bone Mineral Density (BMD) of the Hip (Participants With Percentage Increase). |
10 | — |
| SECONDARY Number of Participants With Fracture |
— | — |
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.
Data sourced from ClinicalTrials.gov (NCT00920075). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.