Postmenopausal Osteoporosis Clinical Trial
Official title:
An Open-Label, Multi-Center Study to Determine Level of Adherence to Monthly Oral or Every Three Month Intravenous Ibandronate Treatment in Post-Menopausal Women With Osteoporosis or Osteopenia, Who Are GI Intolerant of Daily or Weekly Alendronate or Risendronate
Verified date | November 2016 |
Source | Hoffmann-La Roche |
Contact | n/a |
Is FDA regulated | No |
Health authority | USA:FDA |
Study type | Interventional |
The purpose of this study is to evaluate treatment adherence to different regimens of ibandronate in postmenopausal women with osteoporosis or osteopenia who are intolerant to daily or weekly alendronate or risedronate therapy due to gastrointestinal (GI) side effects. The anticipated time on study treatment is 12 months, and the target sample size is 517 individuals.
Status | Completed |
Enrollment | 545 |
Est. completion date | September 2006 |
Est. primary completion date | September 2006 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Women with postmenopausal osteoporosis or osteopenia - Discontinuation of daily and /or weekly alendronate or risedronate therapy because of GI intolerance (eg, heartburn, acid reflux, stomach upset) Exclusion Criteria: - Inability to stand or sit upright for 60 minutes - Inability to swallow a tablet whole - Hypersensitivity to any component of Boniva - Malignant disease diagnosed within previous 10 years (except resected basal cell cancer); contraindications for calcium or vitamin D therapy - Patients who do not fulfill a minimum 3 months wash-out therapy from any previous bisphosphonate therapy |
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Hoffmann-La Roche |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of participants who have greater than or equal to (>=) 75 percent (%) adherence using either monthly oral ibandronate or quarterly intravenous (IV) ibandronate | 12 months | No | |
Secondary | Percentage of participants who have an adherence of >= 75% using ibandronate including both switch and non-switch participants | 12 months | No | |
Secondary | Percentage of participants with GI events based on severity | Up to 10 months | No | |
Secondary | Percentage of participants who experienced a change in frequency and number of GI events | Up to 10 months | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05902078 -
Eldecalcitol and Calcitriol in Postmenopausal Women With Low Bone Mineral Density or Mild Osteoporosis
|
Phase 4 | |
Completed |
NCT05087030 -
Comparative Efficacy and Safety Study of RGB-14-P and Prolia® in Women With Postmenopausal Osteoporosis
|
Phase 3 | |
Completed |
NCT01544894 -
Clinical Study of Raloxifene and Strontium Ranelate in Postmenopausal Osteoporosis
|
Phase 4 | |
Completed |
NCT00377819 -
Study of Transitioning From Alendronate to Denosumab
|
Phase 3 | |
Completed |
NCT00381251 -
Study Comparing Bioequivalence of Two New Formulations of Premarin/MPA With Premarin/MPA Reference Formulation.
|
Phase 1 | |
Completed |
NCT00239629 -
Teriparatide and Strontium Ranelate Head-To-Head Comparison Trial
|
Phase 4 | |
Completed |
NCT04026256 -
Bone Modeling Effects of Combined Anabolic/Antiresorptive Administration
|
Phase 4 | |
Terminated |
NCT00529373 -
A Study of MK-0822 in Postmenopausal Women With Osteoporosis to Assess Fracture Risk (MK-0822-018)
|
Phase 3 | |
Completed |
NCT00092014 -
A Study to Evaluate and Compare Alendronate and Risedronate on Bone Mineral Density in Women With Postmenopausal Osteoporosis (MK-0217-211)
|
Phase 3 | |
Recruiting |
NCT06079476 -
A Study of Romosozumab (EVENITY®) in Postmenopausal Women in India With Osteoporosis at a High Risk of Fracture.
|
Phase 4 | |
Not yet recruiting |
NCT04719650 -
Clinical Pharmacokinetics and Pharmacodynamics Study of Different Doses of Zoledronic Acid
|
Phase 4 | |
Recruiting |
NCT02981732 -
CLCF1 Gene Associated With Postmenopausal Osteoporosis of Kidney Yin Deficiency Syndrome
|
N/A | |
Completed |
NCT01709110 -
VERtebral Fracture Treatment Comparisons in Osteoporotic Women
|
Phase 4 | |
Completed |
NCT01348243 -
Efficacy Of Clodronate 200 Mg/4 Ml I.M. Solution With 1% Lidocaine Every Other Week Vs Clodronate 100 Mg/3,3ml I.M. Solution With 1% Lidocaine Once-Week In A 1-Year Treatment Period Of Women With Postmenopausal Osteoporosis
|
Phase 3 | |
Completed |
NCT00541658 -
A Study of a 35 mg Delayed Release Formulation of Risedronate for Osteoporosis
|
Phase 3 | |
Completed |
NCT00395395 -
Effects of Water and Food Intake on the Pharmacokinetics and Pharmacodynamics of Oral Salmon Calcitonin in Healthy Postmenopausal Women
|
Phase 1 | |
Completed |
NCT00247273 -
A Study of Monthly Risedronate for Osteoporosis
|
Phase 3 | |
Active, not recruiting |
NCT03720886 -
G56W1 in Women With Postmenopausal Osteoporosis
|
Phase 1/Phase 2 | |
Completed |
NCT01668589 -
Observational Study of Denosumab (Prolia®) in Postmenopausal Women With Osteoporosis
|
N/A | |
Completed |
NCT04664959 -
A Study to Compare SB16 (Proposed Denosumab Biosimilar) to Prolia® in Postmenopausal Women With Osteoporosis
|
Phase 3 |