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Risedronate

Phase 3

Osteoporosis | Small molecule | Endocrine |Bone Biologics Corp|Last Updated: Mar 4, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment31

FDA Designations

No designations recorded

Clinical trial landscape

Risedronate · 1 trial · 1 indication

Phase 3 1
NCT01611571Combination Risedronate - Parathyroid Hormone Trial in Male OsteoporosisOsteoporosis
COMPLETED31 Analytics
PHASE3COMPLETED
Combination Risedronate - Parathyroid Hormone Trial in Male Osteoporosis
OsteoporosisUnlock trial analytics

Study Endpoints

Primary Endpoints

Change in Spine Bone Density
18 months

change in spine bone density at 18 months measured by DXA 18 and 24 months

Secondary Endpoints

Change in Hip Bone Density
baseline and 18 months
Change in Forearm Bone Density
baseline and 18 months
New Morphometric Vertebral Fractures
baseline through 18 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Active Risedronate Placebo TeriparatideACTIVE_COMPARATORActive Risedronate + Placebo Teriparatide for 18 months / Active Risedronate for 6 months
Active Risedronate Active TeriparatideACTIVE_COMPARATORActive Risedronate + Active Teriparatide for 18 months / Active Risedronate for 6 months
Placebo Risedronate Active TeriparatideACTIVE_COMPARATORPlacebo Risedronate Active Teriparatide for 18 months / Active Risedronate for 6 months

Interventions

NameTypeDescription
RisedronateDRUGweekly risedronate
TeriparatideDRUGdaily teriparatide
Placebo TeriparatideDRUGdaily placebo of teriparatide
placebo RisedronateDRUGweekly placebo of Risedronic Acid
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Eligibility Criteria

Age Range30 Years to 85 Years
SexMALE
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Males, ages 30-85 with osteoporosis. 2. Osteoporosis can be due to hypogonadism, past steroid use, or idiopathic. 3. Patients with hypogonadism can be included if their replacement dosage of testosterone has been stable for at least 18 months. 4. Bone mineral density must be ...

Countries:United States
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Competitive Landscape -Osteoporosis 8 trials

Frequently asked questions about Risedronate

What is Risedronate used for in osteoporosis?

Risedronate is used for the treatment of osteoporosis. It is a small molecule being developed by Bone Biologics Corp for this condition. In clinical trials, it has been studied in male patients with osteoporosis, with a completed Phase 3 trial evaluating its use in combination with parathyroid hormone.

What does Risedronate target?

Risedronate is a bisphosphonate that works by inhibiting bone resorption. It targets osteoclasts, the cells responsible for breaking down bone tissue, thereby helping to maintain bone density and reduce fracture risk in patients with osteoporosis.

Who makes Risedronate?

Risedronate is being developed by Bone Biologics Corp, a company traded on the NASDAQ under the ticker symbol BBLG. The company is conducting clinical research on this drug for the treatment of osteoporosis.

What phase is Risedronate in?

Risedronate is in Phase 3 clinical development for osteoporosis. A Phase 3 trial has been completed, but the drug is still considered investigational and has not been approved by regulatory authorities. It remains in clinical development.

What clinical trials is Risedronate in?

Risedronate has one completed Phase 3 clinical trial registered under NCT01611571, titled 'Combination Risedronate - Parathyroid Hormone Trial in Male Osteoporosis.' This randomized, double-blind, active-controlled study enrolled 31 male patients aged 30 years and older with osteoporosis in the United States.

Is Risedronate the same as other osteoporosis drugs?

Risedronate is a specific bisphosphonate medication used for osteoporosis. It is not the same as other drugs in its class, such as alendronate or ibandronate, though they share a similar mechanism of action. Risedronate is being studied in combination with parathyroid hormone for male osteoporosis.