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Ibandronate

Phase 3

Postmenopausal Osteoporosis | Small molecule | Endocrine |Amgen Inc.|Last Updated: Feb 11, 2013

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment833

FDA Designations

No designations recorded

Clinical trial landscape

Ibandronate · 1 trial · 1 indication

Phase 3 1
NCT00936897A Study to Evaluate the Safety and Efficacy of Denosumab and Ibandronate in Postmenopausal Women Sub-Optimally Treated With Daily or Weekly BisphosphonatesPostmenopausal Osteoporosis
COMPLETED833 Analytics
PHASE3COMPLETED
A Study to Evaluate the Safety and Efficacy of Denosumab and Ibandronate in Postmenopausal Women Sub-Optimally Treated With Daily or Weekly Bisphosphonates
Postmenopausal Osteoporosis
NCT00936897833
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Study Endpoints

Primary Endpoints

Total Hip Bone Mineral Density Percent Change From Baseline at Month 12
Baseline to month 12

Secondary Endpoints

Serum Type-1 C-Telopeptide Percent Change From Baseline at Month 1
Baseline to month 1
Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 12
Baseline to Month 12
Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12
Baseline to month 12
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
IbandronateACTIVE_COMPARATORIbandronate 150mg PO QM (tablet)
DenosumabEXPERIMENTALdenosumab 60mg Subcutaneous Q6M (pre-filled syringe)

Interventions

NameTypeDescription
IbandronateDRUGIbandronate 150mg PO QM (tablet)
DenosumabDRUGdenosumab 60mg SC Q6M (pre-filled syringe)
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Eligibility Criteria

Age Range55 Years to N/A
SexFEMALE
Healthy VolunteersNo

Inclusion Criteria: * Ambulatory, postmenopausal women (based on medical history) 55 years or older at screening * Postmenopause will be defined as no vaginal bleeding or spotting for at least 12 months * If the subject is 55 - 59 years old and there is uncertainty regarding menopausal status, conf...

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Frequently asked questions about Ibandronate

What is Ibandronate used for?

Ibandronate is used for postmenopausal osteoporosis. It is a small molecule being developed by Amgen Inc. (AMGN) and is currently in Phase 3 clinical development. In a completed Phase 3 trial, it was evaluated in postmenopausal women with osteoporosis who had been sub-optimally treated with daily or weekly bisphosphonates.

Who makes Ibandronate?

Ibandronate is being developed by Amgen Inc., which trades under the ticker AMGN. The drug is a small molecule intended for the treatment of postmenopausal osteoporosis and is currently in Phase 3 clinical development.

What phase is Ibandronate in?

Ibandronate is in Phase 3 clinical development. It is an investigational drug for postmenopausal osteoporosis and has not been approved by the FDA. One Phase 3 trial has been completed, involving 833 participants.

What clinical trials is Ibandronate in?

Ibandronate has one completed Phase 3 clinical trial, NCT00936897, titled 'A Study to Evaluate the Safety and Efficacy of Denosumab and Ibandronate in Postmenopausal Women Sub-Optimally Treated With Daily or Weekly Bisphosphonates.' The trial enrolled 833 postmenopausal women aged 55 years and older with osteoporosis.

Is Ibandronate the same as Denosumab?

No, Ibandronate is not the same as Denosumab. They are different drugs that were studied together in a clinical trial. Ibandronate is a small molecule, while Denosumab is a separate medication. The trial compared the safety and efficacy of both drugs in postmenopausal women with osteoporosis.