Phase 3
Completed N=923
A Study of a 35 mg Delayed Release Formulation of Risedronate for Osteoporosis
Source: ClinicalTrials.gov NCT00541658 ↗Enrolled (actual)
923
Serious AEs
10.3%
Results posted
Jun 2011
Primary outcomePrimary: Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Week 52 / Endpoint, ITT Population — 3.069; 3.302; 3.365 Percent Change
Summary
The purpose of this trial is to study the efficacy of a 35 mg delayed release weekly dosing regimen as compared to the standard daily dosing regimen of risedronate 5 mg daily.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Week 52 / Endpoint, ITT Population |
3.069; 3.302; 3.365 | — |
| SECONDARY Percent Change From Baseline Lumbar Spine BMD for Combined 35 mg Delayed-Release Weekly Treatment Group, Week 52 / Endpoint, ITT Population |
3.069; 3.334 | 0.2955 |
| SECONDARY Percent Change From Baseline Lumbar Spine BMD, Week 26, ITT Population |
2.685; 2.816; 2.529 | — |
| SECONDARY Percent Change From Baseline Lumbar Spine BMD, Week 52, ITT Population |
3.035; 3.293; 3.357 | — |
| SECONDARY Percent Change From Baseline Lumbar Spine BMD at Week 104, ITT Population |
4.352; 5.506; 5.396 | — |
| SECONDARY Percent Change From Baseline Lumbar Spine BMD at Week 104 / Endpoint, ITT Population |
4.147; 5.205; 5.068 | — |
| SECONDARY Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD), Week 52, ITT Population |
81; 87.5; 86.4 | 0.0524 |
| SECONDARY Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD) at Week 52 / Endpoint, ITT Population |
81.5; 87.4; 86.0 | 0.0729 |
| SECONDARY Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD) at Week 104, ITT Population |
82.6; 89.2; 92.3 | 0.0476 sig |
| SECONDARY Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD) at Week 104 / Endpoint, ITT Population |
81.8; 87.9; 90.1 | 0.0547 |
| SECONDARY Percent Change From Baseline in Total Proximal Femur BMD, Week 26, ITT Population |
1.613; 1.748; 1.685 | — |
| SECONDARY Percent Change From Baseline in Total Proximal Femur BMD, Week 52, ITT Population |
1.809; 2.130; 2.099 | — |
| SECONDARY Percent Change From Baseline Total Proximal Femur BMD, Week 52 / Endpoint, ITT Population |
1.785; 2.073; 2.075 | — |
| SECONDARY Percent Change From Baseline Total Proximal Femur BMD, Week 104, ITT Population |
2.177; 2.821; 2.764 | — |
| SECONDARY Percent Change From Baseline Total Proximal Femur BMD, Week 104 / Endpoint, ITT Population |
2.028; 2.551; 2.496 | — |
| SECONDARY Percent Change From Baseline in Femoral Neck BMD, Week 26, ITT Population |
1.120; 1.385; 1.246 | — |
| SECONDARY Percent Change From Baseline in Femoral Neck BMD, Week 52, ITT Population |
1.155; 1.482; 1.717 | — |
| SECONDARY Percent Change From Baseline in Femoral Neck BMD, Week 52 / Endpoint, ITT Population |
1.180; 1.507; 1.717 | — |
| SECONDARY Percent Change From Baseline in Femoral Neck BMD, Week 104, ITT Population |
1.530; 2.108; 2.328 | — |
| SECONDARY Percent Change From Baseline in Femoral Neck BMD, Week 104 / Endpoint, ITT Population |
1.431; 1.986; 2.047 | — |
| SECONDARY Percent Change From Baseline Greater Trochanter BMD, Week 26, ITT Population |
1.900; 2.148; 2.164 | — |
| SECONDARY Percent Change From Baseline in Greater Trochanter BMD, Week 52, ITT Population |
2.297; 2.854; 2.819 | — |
| SECONDARY Percent Change From Baseline in Greater Trochanter BMD, Week 52 / Endpoint |
2.186; 2.732; 2.764 | — |
| SECONDARY Percent Change From Baseline in Greater Trochanter BMD, Week 104, ITT Population |
3.056; 4.152; 4.246 | — |
| SECONDARY Percent Change From Baseline in Greater Trochanter BMD, Week 104 / Endpoint |
2.772; 3.691; 3.828 | — |
| SECONDARY Percent Change From Baseline Urine Type-I Collagen N-telopeptide/ Creatinine (NTX/Cr), Week 13, ITT Population |
-42.595; -46.366; -45.420 | — |
| SECONDARY Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 26, ITT Population |
-43.075; -45.705; -47.692 | — |
| SECONDARY Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 52, ITT Population |
-42.223; -47.263; -46.863 | — |
| SECONDARY Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 52 / Endpoint, ITT Population |
-40.227; -46.599; -44.630 | — |
| SECONDARY Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 104, ITT Population |
-49.188; -53.927; -53.186 | — |
| SECONDARY Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 104 / Endpoint, ITT Population |
-46.261; -51.079; -49.454 | — |
| SECONDARY Percent Change From Baseline Serum Type-I Collagen C-telopeptide (CTX), Week 13, ITT Population |
-42.331; -46.781; -46.054 | — |
| SECONDARY Percent Change From Baseline Serum Type-I Collagen C-telopeptide (CTX), Week 26, ITT Population |
-44.386; -49.183; -49.358 | — |
| SECONDARY Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 52, ITT Population |
-44.410; -49.185; -50.048 | — |
| SECONDARY Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 52 / Endpoint, ITT Population |
-42.172; -48.724; -47.703 | — |
| SECONDARY Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 104, ITT Population |
-44.155; -51.985; -52.538 | — |
| SECONDARY Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 104 / Endpoint, ITT Population |
-41.451; -49.253; -48.752 | — |
| SECONDARY Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 13, ITT Population |
-23.386; -25.141; -25.191 | — |
| SECONDARY Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 26, ITT Population |
-31.273; -33.680; -32.582 | — |
| SECONDARY Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 52, ITT Population |
-31.895; -33.450; -33.507 | — |
| SECONDARY Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 52 / Endpoint, ITT Population |
-31.367; -32.802; -32.829 | — |
| SECONDARY Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 104, ITT Population |
-33.394; -36.143; -36.810 | — |
| SECONDARY Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 104 / Endpoint, ITT Population |
-32.572; -34.769; -34.824 | — |
| SECONDARY Number of Patients With at Least One New Fractured Vertebra, Week 52 |
2; 2; 3 | 1.0000 |
| SECONDARY Number of Patients With at Least One New Fractured Vertebra, Week 52 / Endpoint, ITT Population |
2; 2; 3 | 1.0000 |
| SECONDARY Number of Patients With at Least One New Fractured Vertebra, Week 104, ITT Population |
5; 2; 4 | 0.4505 |
| SECONDARY Number of Patients With at Least One New Fractured Vertebra, Week 104 / Endpoint, ITT Population |
5; 2; 6 | 0.4505 |
| SECONDARY Number of Patients With No New Fractured Vertebra, Week 52 |
255; 255; 254 | 1.0000 |
| SECONDARY Number of Patients With No New Fractured Vertebra, Week 52 / Endpoint |
268; 259; 268 | 1.0000 |
| SECONDARY Number of Patients With No New Fractured Vertebra, Week 104 |
239; 231; 233 | 0.4505 |
| SECONDARY Number of Patients With No New Fractured Vertebra, Week 104 / Endpoint |
269; 263; 267 | 0.4505 |
Eligibility Criteria
Inclusion Criteria
- Female: 50 years of age or older
- >5 years since last menses natural or surgical
- have lumbar spine or total hip BMD more that 2.5 SD below the young adult mean, or have lumbar spine or total hip BMD more than 2.0 SD below the young adult female mean value and also have at least one prevalent vertebral body fracture
Exclusion Criteria
- history of uncontrolled hyperparathyroidism, hyperthyroidism, osteomalacia
- BMI >32 kg/m
- use of medications within 3 months of starting study drug that impact bone metabolism such as glucocorticoids, estrogens, calcitonin, calcitriol, other bisphosphonates and parathyroid hormone
- hypocalcemia or hypercalcemia of any cause
- markedly abnormal clinical laboratory measurements that are assessed as clinically significant by the investigator
Data sourced from ClinicalTrials.gov (NCT00541658). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.