Treatment of postmenopausal osteoporosis in patients at risk of vitamin D insufficiency. MedDRA version: 14.1 Level: PT Classification code 10031285 Term: Osteoporosis postmenopausal System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Sponsors
Teva Pharmaceutical Industries Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 18 years and older 2. Patients in good general health, according to the investigator?s judgment 3. Serum 25-hydroxy vitamin D =9 ng/ml 4. Normal (within reference range) iPTH and BSAP for patients with serum 25-hydroxy vitamin D =9 ng/ml and 35 IU/l in patients =65 years) yes F.1.3.1 Number of subjects for this age range 630
Exclusion criteria
Exclusion criteria: 1. Hypersensitivity to the active substances or to any of the excipients, or to any related drug 2. Bone fractures within 3 months prior to screening 3. Inability to stand or sit upright for at least 30 minutes 4. Inability to take the study drugs as recommended: after getting up for the day with a full glass of water (not less than 200 ml) 5. Active upper gastrointestinal problems, such as dysphagia, esophageal disease, gastritis, duodenitis, ulcers 6. Recent history (within the previous year) of major gastrointestinal disease such as peptic ulcer, or active gastrointestinal bleeding, or surgery of the upper gastrointestinal tract other than pyloroplasty 7. Known Barrett's esophagus 8. Malabsorption 9. Hypocalcemia: serum calcium <2.1 mmol/l (9 mg/dl) 10. Concomitant malignancy except carcinoma in situ not needing other than local therapy 11. History of solid tumors not curatively treated or showing a recurrence within the last 5 years 12. Concomitant untreated severe periodontal disease 13. Renal impairment (glomerular filtration rate less than 35 ml/min) 14. Presence of bone or mineral metabolism disorders, other than idiopathic osteoporosis (e.g. hyperparathyroidism, hyperthyroidism, osteomalacia of other origin, Paget?s disease of bone, glucocorticoid-induced osteoporosis) 15. Diseases associated with unregulated overproduction of calcitriol (e.g. leukemia, lymphoma, sarcoidosis). 16. Previous or concomitant intake of drugs and/or food additives restricted by the protocol (for a complete list please see chapter 8.6.6, page 38). 17. Pregnancy or lactation 18. Simultaneous participation in another clinical study or participation in any clinical study involving an investigational drug within 3 months prior to start of the present study 19. Severe physical or mental concomitant diseases that might hamper the realization of the trial according to protocol 20. History of alcohol or drug addiction 21. Legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible consequences of the study 22. Unreliability or lack of cooperation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of the present trial is to estimate the proportion of patients with 25-hydroxy vitamin D insufficiency (<15 ng/ml) after 15 weeks of treatment with two oral test products containing alendronate sodium/cholecalciferol 70 mg/0.07 mg or 70 mg/0.14 mg (Alendronate/cholecalciferol (Teva Pharmaceutical Industries Ltd.)) as compared to alendronate alone Fosamax®.;Secondary Objective: The secondary objectives of the present trial are: - To evaluate the efficacy of both test products as compared to Fosamax® alone in reducing the proportion of patients with 25-hydroxy vitamin D deficiency (<9 ng/ml) after 15 weeks of treatment. - To assess the difference in the mean serum 25-hydroxy vitamin D between both test products and the reference product after 15 weeks of treatment. - To assess the percent change from baseline in the serum concentrations of intact serum parathyroid hormone (iPTH) between both test products and the reference product after 15 weeks of treatment. - To evaluate the changes from baseline in the rate of bone turnover as assessed by biochemical markers (bone-specific alkaline phosphatase (BSAP) and urine N-telopeptides of type 1 colloagen corrected for creatinine (NTx/Cr)).;Primary end point(s): The primary endpoint in the present trial is the proportion of patients with 25-hydroxy vitamin D insufficiency (<15 ng/ml) after 15 weeks of treatment. This endpoint undergoes descriptive and comparative statistical evaluation ;Timepoint(s) of evaluation of this end point: after 15 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): a) proportion of patients with 25-hydroxy vitamin D deficiency (<9 ng/ml) after 15 weeks of treatment, b) mean serum concentration of 25-hydroxy vitamin D after 15 weeks of treatment, c) percent change from baseline in intact serum parathyroid hormone (iPTH) after 15 weeks of treatment d) changes from baseline in the rate of bone turnover as assessed by biochemical markers (bone-specific alkaline phosphatase (BSAP) and urine N-telopeptides of type 1 colloagen corrected for creatinine (NTx/Cr));Timepoint(s) of evaluation of this end point: after 15 weeks of treatment | — |
Countries
Poland
Contacts
Public ContactDr. Ekkehard Baader
Teva Pharma GmbH
Outcome results
None listed