Clinical trial · Interventional
Fosamax for Childhood Cancer Survivors
Randomized Controlled Study on the Benefits and Safety of Bisphosphonate Treatment in Childhood Cancer Survivors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Survivors of childhood cancers face a variety of long-term problems. The investigators' recent study found that osteoporosis and osteopenia were common among these patients. The factors leading to, as well as the best treatment option for, this morbidity are unclear. Bisphosphonates are currently the standard therapy for osteoporosis in the elderly. However, the efficacy and safety of bisphosphonates for treating osteoporosis in long-term cancer survivors have not been tested. The investigators hypothesize that alendronate, an orally active bisphosphonate, is efficacious and safe in the treatment of osteoporosis in these patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Osteoporosis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Alendronate | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Alendronate
- description
- Oral alendronate 70 mg weekly
- interventionNames
- Drug: Alendronate
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Conventional drug treatment
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- The percent change in bone mineral density (BMD) at lumbar spine at 36-weeks in subjects who receive active and control treatments
- timeFrame
- 36 weeks
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
Show eligibility criteria text
Inclusion Criteria: * Chinese patients who completed treatments for childhood cancers for at least 5 years * Currently followed up in the Department of Paediatrics of Prince of Wales Hospital * Younger than 18 years old at the time of diagnosis of underlying cancers * Evidence of osteoporosis (i.e. BMD T- or Z-score \< -2.5 at lumbar spine) * Older than 15 years of age at the time of recruitment Exclusion Criteria: * Current treatment (i.e. within 6 months) with maintenance systemic or high-dose inhaled corticosteroids * Subjects who cannot cooperate for BMD measurements * Pregnant female patients * Subjects with prior history of allergy to alendronate or in whom alendronate treatment is contraindicated
References
Publications (0)
Data not yet available