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PTH/Calcium

Phase 3

Osteoporosis | Small molecule | Endocrine |Takeda Pharmaceutical Company Limited|Last Updated: May 25, 2021

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment374

FDA Designations

No designations recorded

Clinical trial landscape

PTH/Calcium · 1 trial · 1 indication

Phase 3 1
NCT00172172Calcium Supplementation in Postmenopausal WomenOsteoporosis
COMPLETED374 Analytics
PHASE3COMPLETED
Calcium Supplementation in Postmenopausal Women
OsteoporosisUnlock trial analytics

Study Endpoints

Primary Endpoints

Evaluate subjects treated with ALX1-11 (no calcium supplementation) increase in BMD is less than those treated with ALX1-11 (receiving calcium supplementation).
6 months
Primary efficacy variable is the percentage change from baseline of lumbar vertebral BMDmeasured by DXA.
6 months

Secondary Endpoints

BMC,
6 months
vBMD,
6 months
the incidence of clinical fractures,
6 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALPTH 100 mcg and 700 mg calcium
2EXPERIMENTALPTH 100 mcg and placebo
3PLACEBO_COMPARATORPlacebo and 700 mg calcium

Interventions

NameTypeDescription
PTH/CalciumDRUGPTH(1-84) subcutaneous injection and calcium 700 mg oral
PTH/placeboDRUGPTH (1-84) injected subcutaneously and placebo provided orally
placeboDRUGPlacebo injected subcutaneously and 700 mg calcium orally
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Eligibility Criteria

Age Range45 Years to N/A
SexFEMALE
Healthy VolunteersNo
Study Sites27

Inclusion Criteria: * Women who are capable of understanding and giving written, voluntary informed consent before the clinical study screening visit * Women with the ability to self-administer a daily injection or having a designee who will give the injections * Women who are postmenopausal with a...

Countries:United StatesArgentinaMexico
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Competitive Landscape -Osteoporosis 8 trials

Frequently asked questions about PTH/Calcium

What is PTH/Calcium used for?

PTH/Calcium is an investigational small molecule being studied for the treatment of osteoporosis in postmenopausal women. It is currently in Phase 3 clinical development and has not been approved by regulatory authorities.

Who makes PTH/Calcium?

PTH/Calcium is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with osteoporosis.

What phase is PTH/Calcium in?

PTH/Calcium is in Phase 3 clinical development. It is an investigational drug and has not yet received regulatory approval. The Phase 3 trial has been completed, and the drug remains under evaluation for the treatment of osteoporosis.

What clinical trials is PTH/Calcium in?

PTH/Calcium has one completed Phase 3 clinical trial registered under NCT00172172, titled "Calcium Supplementation in Postmenopausal Women." The trial enrolled 374 participants with osteoporosis across the United States, Argentina, and Mexico.

Is PTH/Calcium the same as calcium supplementation?

PTH/Calcium is a drug being studied for osteoporosis, and its Phase 3 trial is titled "Calcium Supplementation in Postmenopausal Women." The trial evaluates the drug in postmenopausal women aged 45 years and older with osteoporosis.