Efficacy & Safety of ViaDerm-hPTH(1-34) Compared to Forteo SC in Postmenopausal Women With Osteoporosis

TransPharma Medical

Status and phase: Completed; Phase 2

Conditions: Osteoporosis

Treatments: Drug: Teriparatide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00535860

I2Y-MC-GHFE

CS 82-000-04

Details and patient eligibility

About

The purpose of this study is to assess the clinical efficacy, safety, and tolerability of ViaDerm-shPTH [1-34] transdermal delivery in comparison to subcutaneous injection of rhPTH[1-34] following 3-month treatment in postmenopausal women with Osteoporosis

Enrollment: 104 patients

Sex: Female

Ages: 55 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Main Inclusive Criteria:

• Post-menopausal women aged between 55 to 85 years (inclusive)
• Posterior-Anterior lumbar vertebral and/or femoral neck BMD T-score by DXA ≤-2.5 SD.
• Have normal serum PTH, thyroid stimulating hormone (TSH) (only for patients treated with thyroid hormone), and prolactin values.

Main Exclusive Criteria:

• Subjects who have a clinical significant or unstable medical or surgical condition that may preclude safe and complete study participation
• Current diagnoses of disorders known to affect bone metabolism including hyperthyroidism, hyperparathyroidism, osteomalacia, or Paget's disease
• Prior osteoporosis treatment with fluoride or strontium at any time; or any IV treatment with bisphosphonates in the past or oral bisphosphonate for more than 1 month in the past 24 months prior to randomization.
• Any condition or disease that may interfere with the ability to have, or to evaluate a DXA scan

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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104 participants in 3 patient groups

50 mcg

Experimental group

Description:

ViaDerm transdermal delivery

Treatment:

Drug: Teriparatide

80 mcg

Experimental group

Description:

Add Via-Derm transdermal delivery

Treatment:

Drug: Teriparatide

20 mcg

Active Comparator group

Description:

Subcutaneous injection

Treatment:

Drug: Teriparatide