Recent Updates
Recently added Catalysts

PTH134

Phase 1

Post-menopausal Osteoporosis | Small molecule | Endocrine |Novartis AG|Last Updated: May 13, 2011

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment104

FDA Designations

No designations recorded

Clinical trial landscape

PTH134 · 2 trials · 2 indications

Phase 1 2
NCT01224717Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral Doses of PTH134 in Post-menopausal WomenPost-menopausal Osteoporosis
COMPLETED104 Analytics
NCT00676312Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Effect of PTH134 at Increasing Doses in Healthy Postmenopausal SubjectsPostmenopausal Osteoporosis
COMPLETED32 Analytics
PHASE1COMPLETED
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral Doses of PTH134 in Post-menopausal Women
Post-menopausal Osteoporosis
NCT01224717104
Unlock trial analytics
PHASE1COMPLETED
Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Effect of PTH134 at Increasing Doses in Healthy Postmenopausal Subjects
Postmenopausal Osteoporosis
NCT0067631232
Unlock trial analytics

Study Endpoints

Primary Endpoints

Measure: Effects of treatment on bone biomarkers. Measure levels of PINP, CTX-1, and serum calcium levels, serum phosphate, P1CP, bone-specific alkaline phosphatase, osteocalcin.
12 weeks
•Safety and tolerability of ascending single doses of PTH134 over 24 hours as compared to baseline. •Pharmacokinetics after ascending single doses of PTH134, including comparison with reference drug Forteo 20 µg sc over 24 hours.

Secondary Endpoints

Change from baseline in serum calcium levels after 12 weeks of treatment
12 weeks
•Assessment of PK from PTH134 formulations over 24 hours. •Assessment of the pharmacodynamic profile of serum ionized calcium, total serum calcium, bone biomarkers with reference drug Forteo 20 µg and placebo over 24 hours.
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PTH134EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
ForsteoACTIVE_COMPARATOR -
1EXPERIMENTALCross-over treatment with increasing doses of PTH134, placebo and active comparator.

Interventions

NameTypeDescription
PTH134DRUG -
PlaceboDRUG -
ForsteoDRUG -
Unlock Study Design Details

Eligibility Criteria

Age Range45 Years to 80 Years
SexFEMALE
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * Post-menopausal women osteoporotic/osteopenic with an additional risk factor 45 to 80 years old Exclusion Criteria: * Use of estrogen or hormone replacement therapy * Use of parathormone or parathormone fragments, calcitonin, aluminum supplements, within 12 months prior to f...

Countries:DenmarkGermanySwitzerland
Unlock Eligibility Criteria

Frequently asked questions about PTH134

What is PTH134 used for?

PTH134 is an investigational small molecule being developed by Novartis AG for the treatment of postmenopausal osteoporosis, a condition characterized by weakened bones in women after menopause. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

How does PTH134 work?

PTH134 is a small molecule designed to target pathways involved in bone metabolism. While the specific molecular target has not been disclosed, it is being studied for its effects on bone density in postmenopausal women with osteoporosis.

Who is developing PTH134?

PTH134 is being developed by Novartis AG, a multinational pharmaceutical company listed on the New York Stock Exchange under the ticker symbol NVS. The drug is currently in Phase 1 clinical trials for postmenopausal osteoporosis.

What phase is PTH134 in?

PTH134 is in Phase 1 clinical development. It has completed two Phase 1 trials, with a total enrollment of 104 participants. The drug is investigational and has not yet received approval from the FDA or other regulatory agencies.

What clinical trials has PTH134 been in?

PTH134 has been studied in two completed Phase 1 trials. The first, NCT00676312, enrolled 32 healthy postmenopausal women in Switzerland. The second, NCT01224717, enrolled 104 postmenopausal women in Denmark and Germany. Both trials assessed safety, tolerability, pharmacokinetics, and pharmacodynamics.

Is PTH134 the same as any other drug?

PTH134 is a unique investigational compound developed by Novartis. No alternative names or brand names have been associated with this drug in clinical trial records. It is distinct from other osteoporosis treatments currently on the market.