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| Name | Class |
|---|---|
| Procter and Gamble | INDUSTRY |
The primary objective of this pilot study is to estimate the percent change from baseline at Week 4, Month 6 in NTX bone turnover marker for a monthly 150mg dose of risedronate administered for 6 months and a loading dose regimen of risedronate over a 6 month treatment period both compared to a 5 mg daily dose of risedronate for 6 months
The secondary objectives are :
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RISEDRONATE | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Urine NTX at week 4 of month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Urine NTX at other visits, serum CTX and bone specific alkaline phosphatase, lumbar spine BMD |
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Inclusion Criteria:
ambulatory women,postmenopausal >= 5 years
have lumbar spine baseline BMD within the following criterion :
be in general good health as determined by medical history, physical examination and laboratory tests
Exclusion Criteria:
serum 25-OH vitamin D level <= 12 ng/ml
history of osteomalacia
history of active hyperparathyroidism or hyperthyroidism
hypocalcemia or hypercalcemia from any cause
depot injection >10,000 IU Vitamin D in the past 9 months prior to starting the investigational product
use of Vitamin D supplementation within 3 months prior to starting the investigational product
use of any of the following medications within a specified number of months prior to starting the investigational product :
any allergic or abnormal reaction to bisphosphonates
creatinine clearance < 30 ml/min
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
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| ID | Term |
|---|---|
| D015663 | Osteoporosis, Postmenopausal |
| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D000068296 | Risedronic Acid |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
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| D008659 |
| Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |