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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2009-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study for the Transdermal Application of Teriparatide

NCT01011556

Osteoporosis

COMPLETED PHASE2

Teriparatide (PTH) and Bone Strength in Postmenopausal Women

NCT01155245

Osteoporosis

UNKNOWN

Compliance and Acceptance of Teriparatide Injection in Severely Osteoporotic Patients

NCT00191802

Osteoporosis

COMPLETED PHASE3

A Study for Teriparatide in Severe Osteoporosis

NCT00696644

Osteoporosis, Postmenopausal Osteoporosis

COMPLETED

2-Year Therapy With Teriparatide vs 1-yr Therapy Followed by 1-Year of Raloxifene or Calcium/Vit D in Severe Postmenopausal Osteoporosis

NCT00191425

Osteoporosis, Postmenopausal

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Osteoporosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

50 mcg

ViaDerm transdermal delivery

Group Type EXPERIMENTAL

Teriparatide

Intervention Type DRUG

Daily for 96 days

80 mcg

Add Via-Derm transdermal delivery

Group Type EXPERIMENTAL

Teriparatide

Intervention Type DRUG

Daily for 96 days

20 mcg

Subcutaneous injection

Group Type ACTIVE_COMPARATOR

Teriparatide

Intervention Type DRUG

Daily for 96 days

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Teriparatide

Daily for 96 days

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Forteo Forsteo LY333334

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion 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

Minimum Eligible Age

55 Years

Maximum Eligible Age

85 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No