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Actonel

Phase 3

Osteoporosis | Small molecule | Endocrine |Amgen Inc.|Last Updated: Jul 28, 2020

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment870

FDA Designations

No designations recorded

Clinical trial landscape

Actonel · 1 trial · 1 indication

Phase 3 1
NCT00919711Study to Evaluate the Safety and Efficacy of Denosumab and Actonel® in Post Menopausal Women Transitioned From Alendronate TherapyOsteoporosis
COMPLETED870 Analytics
PHASE3COMPLETED
Study to Evaluate the Safety and Efficacy of Denosumab and Actonel® in Post Menopausal Women Transitioned From Alendronate Therapy
Osteoporosis
NCT00919711870
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Study Endpoints

Primary Endpoints

Total Hip BMD Percent Change From Baseline at Month 12
Baseline to month 12

Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry

Secondary Endpoints

Serum CTX Percent Change From Baseline at Month 1
Baseline to month 1
Femoral Neck BMD Percent Change From Baseline at Month 12
Baseline to month 12
Lumbar Spine BMD 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
Denosumab 60 mgEXPERIMENTAL -
Risedronate 150 mg QMACTIVE_COMPARATOR -

Interventions

NameTypeDescription
Actonel®DRUGOral Actonel® (Risedronate) in total a 150mg per month (one 75mg tablet to be taken on each of 2 consecutive days per month).
DenosumabDRUGDenosumab 60 mg, once every 6 months, Subcutaneous
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Eligibility Criteria

Age Range55 Years to N/A
SexFEMALE
Healthy VolunteersNo

Inclusion Criteria: * Ambulatory, post menopausal women aged 55 years or older at screening. Have received their first prescription of daily or weekly alendronate therapy, for the treatment for post menopausal osteoporosis at least 1 month prior to screening. Use of raloxifene, calcitonin or hormon...

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Competitive Landscape -Osteoporosis 8 trials

CompanyTickerTrialsLead PhaseDrugs
Zimmer Biomet Holdings, Inc.ZBH1 - Undisclosed
Precision BioSciences, Inc.DTIL1N/AUndisclosed
SI-BONE, Inc.SIBN1 - Undisclosed
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Frequently asked questions about Actonel

What is Actonel used for?

Actonel is a small molecule drug being studied for the treatment of osteoporosis. It is currently in Phase 3 clinical development. The drug is being evaluated in postmenopausal women with osteoporosis, and it is intended to address bone loss associated with this condition.

Who makes Actonel?

Actonel is being developed by Amgen Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol AMGN. The drug is currently in Phase 3 clinical trials for the treatment of osteoporosis.

What phase is Actonel in?

Actonel is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 3 trial has been completed, and the drug is being studied for the treatment of osteoporosis in postmenopausal women.

What clinical trials is Actonel in?

Actonel has been studied in a Phase 3 clinical trial registered as NCT00919711. This completed trial, titled "Study to Evaluate the Safety and Efficacy of Denosumab and Actonel® in Post Menopausal Women Transitioned From Alendronate Therapy," enrolled 870 postmenopausal women aged 55 years and older with osteoporosis.

Is Actonel the same as Denosumab?

No, Actonel is not the same as Denosumab. Actonel is a small molecule drug, while Denosumab is a separate drug. In the clinical trial NCT00919711, both drugs were evaluated together in postmenopausal women with osteoporosis who were transitioning from alendronate therapy.