Clinical trial · Interventional
Study of Adults With Low Growth Hormone Who Survived Childhood Cancer Where Treatment Caused Low Bone Density
Treatment of Childhood Cancer Therapy-induced Osteopenia in Growth Hormone Deficient Adult Survivors: Does Bisphosphonate Treatment Improve Bone Mineral Density?
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): due to low enrollment, participants are no longer being examined or treated
Summary
Brief summary (as posted)
The purpose of this project is to evaluate the hypothesis that bisphosphonate treatment given to growth hormone deficient patients (regardless of current growth hormone replacement therapy status and without changing that status) significantly increases total body bone mineral density during an eighteen month period of treatment combined with calcium and Vitamin D when compared to calcium and Vitamin D treatment alone.
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 |
|---|---|---|---|
| Osteopenia | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bisphosphonate therapy (risedronate) | Drug | — | UNRESOLVED |
| Calcium | Dietary Supplement | — | UNRESOLVED |
| Vitamin D supplement | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Growth Hormone only
- description
- No bisphosphonate therapy given, participants will take Vitamin D 400 IU daily for 18 months, as well as calcium carbonate 500 mg twice a day for 18 months.
- interventionNames
- Dietary Supplement: Vitamin D supplement
- Dietary Supplement: Calcium
- type
- EXPERIMENTAL
- label
- Growth Hormone & Bisphosphonate Therapy
- description
- Bisphosphonate Therapy-Risedronate 35 mg once a week for 18 months, Vitamin D 400 IU daily for 18 months and calcium carbonate 500 mg twice daily for 18 months
- interventionNames
- Drug: bisphosphonate therapy (risedronate)
- Dietary Supplement: Vitamin D supplement
- Dietary Supplement: Calcium
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Growth hormone deficiency as a complication of treatment for pediatric malignancy * Dexa (bone densitometry)with z-scores of \< -1.0 in at least one site Exclusion Criteria: * Dexa (bone densitometry)with z-scores \< -1.0 in at least one site * Subjects \<18 years old * Pregnant or lactating patients * Any contraindication for or unwillingness to consider bisphosphonate treatment * Inability or unwillingness to undergo bone density evaluation * Other correctable causes of decreased bone mineral density
References
Publications (0)
Data not yet available