Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
FOSAVANCE 5600 · 1 trial · 1 indication
Percentage of participants with serum levels of 25-hydroxyvitamin D below 20 nanograms/milliliter (ng/mL) after 26 weeks of treatment with FOSAVANCE 5600 once weekly versus Referred-Care in postmenopausal women with osteoporosis and at increased risk of falls.
| Arm | Type | Description |
|---|---|---|
| FOSAVANCE 5600 | EXPERIMENTAL | alendronate sodium (+) cholecalciferol |
| Referred-Care Model | OTHER | Usual treatment for osteoporosis chosen and prescribed by patients' own physicians. |
| Name | Type | Description |
|---|---|---|
| FOSAVANCE 5600 (Alendronate Sodium (+) cholecalciferol) | DRUG | FOSAVANCE 5600 international units (IU)(Alendronate Sodium 70 mg/Vitamin D 5600 IU) combination tablet once weekly for 6 months (Week 26) during the base period and an additional 6-month extension period (Week 52). |
| Calcium Supplement 500 mg | DIETARY_SUPPLEMENT | Calcium supplied locally by the investigator (containing 500 mg calcium supplement) daily for 52 weeks (unless the patient's dietary intake of calcium exceeds 1000 mg per day). |
| Referred-Care Model | OTHER | Usual treatment for osteoporosis chosen and prescribed by patients' own physicians for 6 months (Week 26) during the base period and an additional 6-month extension period (Week 52). |
Inclusion Criteria: * Female * 65 years or older * Diagnosed with osteoporosis (Bone Mineral Density (BMD) T-score \<= -2.5 at spine or hip) or prior fragility fracture BMD T-score \<=-1.5 in at least one of the anatomic sites including lumbar spine, total hip, and femoral neck sites * Postmenopaus...
FOSAVANCE 5600 is used for the treatment of osteoporosis. It is a small molecule combination therapy developed by Organon & Co. for patients with this endocrine condition. The clinical development program has focused on postmenopausal women with osteoporosis, including those with vitamin D inadequacy.
FOSAVANCE 5600 is developed by Organon & Co., which trades under the ticker OGN. Organon is the sponsor of the clinical program for this osteoporosis therapy.
FOSAVANCE 5600 is in Phase 3 clinical development. It is an investigational therapy and has not been approved by the FDA. The Phase 3 program includes one completed trial, and no active trials are currently listed.
FOSAVANCE 5600 has been studied in one Phase 3 clinical trial, NCT00692913, titled A Study to Test the Effect of MK0217A on Vitamin D Inadequacy in Postmenopausal Women With Osteoporosis. This completed trial enrolled 515 participants, was randomized and controlled, and included women aged 65 years and older.