Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Compare the data obtained with two formulations of alendronate 70 mg (tablets vs effervescent tablet for buffered solution) on the change in bone turnover markers, on gastric tolerance and on treatment adherence (including compliance and persistence).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fosamax® | 1 group will be treated with alendronate 70 mg tablets (Fosamax®) |
| |
| Binosto® | 1 group will be treated with alendronate 70 mg effervescent tablets for buffered solution (Binosto®) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Binosto 70Mg Effervescent Tablet | Drug | Assess the effect of alendronate 70mg effervescent tablet on bone turnover markers and patient reported outcomes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| s-CTX | Decrease in the rate of the bone resorption marker s-CTX | Change at 6 months, 12 months, 18 months after treatment start |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Post-menopausal women with osteoporosis, on treatment with Fosamax® or Binosto® for 6-8 months and who will be continued to be treated for a minimum of 12 months, with available BTMs, biochemistry and DXA at the initiation are to be offered participation in the study at the discretion of the treating physician.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aurélie TIREFORD, PharmD | Contact | +41 22 593 78 54 | aurelie.tireford@labatec.com |
| Name | Affiliation | Role |
|---|---|---|
| Aurélie TIREFORD, PharmD | Labatec Pharma SA | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Endokrinologische Praxis & Labor | Recruiting | Basel | Canton of Basel-City | 4055 | Switzerland |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D015663 | Osteoporosis, Postmenopausal |
| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D019386 | Alendronate |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
| Fosamax 70Mg Tablet | Drug | Assess the effect of alendronate 70mg tablet on bone turnover markers and patient reported outcomes. |
|
| Hôpital Universitaire de Genève, Service des maladies osseuses | Recruiting | Geneva | Canton of Geneva | 1211 | Switzerland |
|
| D008659 |
| Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004304 |
| Dosage Forms |
| D004364 | Pharmaceutical Preparations |