Clinical trial · Interventional
Bone Health in Gynecologic Cancers-does FOSAVANCE Help?
The Impact of Bisphosphonates on Bone Loss in Patients Undergoing Surgery and Postoperative Chemotherapy for Gynecologic Malignancies.
- 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)
Women who undergo bilateral oophorectomy and receive chemotherapy are at risk of increased bone loss. At present, despite having a risk factor profile that fits the indications for assessment and treatment there are no routine interventions in this patient population i.e., the standard treatment is no treatment. We hope to identify whether or not an intervention may be favorable in these women and change the standard of care in this vulnerable population. Hypothesis: Weekly therapy with alendronate + vitamin D (FOSAVANCE) will improve bone health as measured by DEXA scans in women with gynecologic malignancies undergoing chemotherapy as compared with patients receiving placebo.
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 |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| alendronate/cholecalciferol | Drug | — | UNRESOLVED |
| placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 1
- description
- FOSAVANCE (70 mg/2800 IU of alendronate and cholecalciferol) or placebo will be given weekly for 1 years duration
- interventionNames
- Drug: alendronate/cholecalciferol
- type
- PLACEBO_COMPARATOR
- label
- 2
- interventionNames
- Drug: placebo
Primary outcomes (1)
- measure
- Bone mineral density
- timeFrame
- 12 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Postmenopausal (surgical extirpation of ovaries) 2. Primary ovarian or endometrial cancer 3. Planned to receive multiagent chemotherapeutic regimen for 6 cycles 4. Signed informed consent 5. BMD T-score between -2.5 and 0 at any site Exclusion Criteria: 1. Renal insufficiency with CrCl \< 35mL/min 2. BMD T-score \< -2.5 at any site 3. Medication, excessive alcohol intake, or GI disease inhibiting GI absorption 4. Metabolic bone disease, bony metastases, poorly controlled thyroid or parathyroid conditions, Paget's disease, or on hormonal therapy/other treatments for OP 5. Abnormalities of the esophagus which delay esophageal emptying i.e., achalasia 6. Inability to stand or sit upright for at least 30 minutes 7. Hypersensitivity to any component of the drug product 8. Requiring/planned external beam radiation during study period 9. Baseline serum 25(OH) vitamin D levels of \< 9ng/mL
References
Publications (0)
Data not yet available