Phase 2
N=22
Safety and Efficacy of Alendronate (Fosamax) in Children With Osteoporosis
Osteoporosis
Bottom Line
View on ClinicalTrials.gov: NCT00259857 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Jan 2011
Primary outcome: Primary: Number of Participants With Improvement in Bone Mineral Density (BMD) of Spine After Therapy — 10; 9 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Alendronate (Drug)
- Age
- Pediatric · 5+ yrs
- Sex
- All
- Sponsor
- Medical University of South Carolina
- Primary completion
- Mar 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Improvement in Bone Mineral Density (BMD) of Spine After Therapy |
10; 6 | — |
| PRIMARY Number of Participants With Improvement in Bone Mineral Density (BMD) of Spine After Therapy |
10; 6 | — |
| SECONDARY Number of Participants With Improvement in Bone Mineral Density (BMD) of Hip After Therapy |
10; 9 | — |
| SECONDARY Number of Participants With Improvement in BMD of Hip |
10; 6 | — |
| SECONDARY Participants With Atraumatic Fractures |
0; 0 | — |
| SECONDARY Participants With Atraumatic Fractures |
0; 0 | — |
Summary
We have previously evaluated the safety and efficacy of Alendronate in 10 patients with juvenile osteoporosis during a 12-month clinical trial. We have documented that Alendronate improved BMD of the spine and hip without any major side effects. There were no additional fractures during therapy. The present study is designed to further evaluate the safety and efficacy of Alendronate in 20 children with juvenile osteoporosis using a double-blind, randomized, placebo-controlled, cross-over protocol.
Eligibility Criteria
Eligibility Criteria:
- 5-15 yrs of age
- Weighing 20 kg and more
- History of multiple fractures
- Tanner stage II or less
- Osteoporosis by DXA.
Inclusion Criteria
- Male and female children with a history of one or more atraumatic fractures, or evidence of one or more compression fractures on radiographs of the spine (reduction of >20 percent).
- Bone Mineral Density (BMD) determined by DXA sacn to confirm osteoporosis at a Z score greater than 2 SD (standard deviations) below the normal mean for age (Z score 1.5 mg/dl.
- Liver dysfunction as indicated by serum SGPT > 2 times the upper limit for age or serum total bilirubin > 2.0 mg/dl.
- Diagnosis of osteogenesis imperfecta, a family history of osteogenesis imperfecta, blue sclerae or deafness.
- Diagnosis of active rickets or osteomalacia or serum bone alkaline phosphatase 2 times greater than normal for age.
- Pregnancy
- Anorexia Nervosa
Data sourced from ClinicalTrials.gov (NCT00259857). 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.