Advertisement

Topics

A Study for the Transdermal Application of Teriparatide

2014-08-27 03:18:03 | BioPortfolio

Summary

The primary purpose of this study is to help answer the following research questions:

1. How teriparatide given using a skin patch (transferred through the skin using the ViaDerm Teriparatide System) compares to teriparatide injected under the skin with a needle (pen injector) affects your bone density (how solid or porous your bones are).

2. The safety of the teriparatide skin patch and any side effects that might be associated with it.

Description

Teriparatide 20 mcg/day is currently only available as a subcutaneous (SQ) injection and many patients with severe osteoporosis for whom anabolic therapy with teriparatide is appropriate are either unwilling or physically unable to self-inject. The purpose of this Phase 2 study is to identify a transdermal dose or doses that will be comparable to the teriparatide 20 mcg SQ dose from a pharmacodynamic (PD) and safety standpoint for use in future Phase 3 studies.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Conditions

Osteoporosis

Intervention

Subcutaneous Teriparatide, Transdermal Teriparatide

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559)
Buenos Aires
Argentina
C1128AAF

Status

Recruiting

Source

Eli Lilly and Company

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:18:03-0400

Clinical Trials [926 Associated Clinical Trials listed on BioPortfolio]

Acute Effect of Teriparatide With Bisphosphonate or Denosumab on Bone Resorption

The aim of the study is to assess the relative antiresorptive properties of 2 osteoporosis medications when combined with teriparatide.

Combined Use of Teriparatide and Raloxifene in Postmenopausal Women With Osteoporosis

The purpose of this study is to compare treatment with both teriparatide and raloxifene with teriparatide alone. The study will evaluate any side effects that may be associated with the t...

Continuous Versus Cyclic Treatment With Teriparatide and Alendronate Combined or Teriparatide Alone in Women With Osteoporosis

Osteoporosis is a disease that affects millions of individuals in the United States and abroad. It leads to decreased bone mass and causes an increased risk of fracture. This study will co...

Teriparatide Use in Hip Replaced Subjects

A pilot study on the use of Teriparatide in severe osteoporotic women with hip fracture and submitted to hip replacement The primary objective of this study is to obtain preliminary data,...

Clinical Trial of Teriparatide in Japan

The purpose of this study is to assess the Efficacy and Safety of Teriparatide in Japanese Postmenopausal Women with Osteoporosis.

PubMed Articles [1318 Associated PubMed Articles listed on BioPortfolio]

Real-world effectiveness of teriparatide on fracture reduction in patients with osteoporosis and comorbidities or risk factors for fractures: Integrated analysis of 4 prospective observational studies.

Teriparatide significantly reduces fracture rates in clinical trials; however, those study populations were relatively restricted and included too few patients to analyze fracture outcomes within clin...

Effect of intermittent teriparatide (PTH 1-34) on the alveolar healing process in orchiectomized rats.

To evaluate intermittent teriparatide therapy's influence on the alveolar healing process in rats with induced osteoporosis.

Effects of teriparatide on hip and upper limb fractures in patients with osteoporosis: A systematic review and meta-analysis.

In randomized clinical trials (RCTs) with teriparatide, the number of patients with incident hip fractures was small and insufficiently powered to show statistically significant differences between gr...

Combined Teriparatide and Denosumab Therapy Accelerates Spinal Fusion following Posterior Lumbar Interbody Fusion.

Previous studies reported that teriparatide (recombinant human parathyroid hormone) accelerated spinal fusion following posterior lumbar inter-body fusion surgery, and combination therapy using teripa...

Reduction of Hip and Other Fractures in Patients Receiving Teriparatide in Real-World Clinical Practice: Integrated Analysis of Four Prospective Observational Studies.

The phase 3 teriparatide Fracture Prevention Trial showed significant reductions in vertebral (VF) and nonvertebral (NVF) fractures; however, patient exposure was insufficient for full analysis of low...

Medical and Biotech [MESH] Definitions

A polypeptide that consists of the 1-34 amino-acid fragment of human PARATHYROID HORMONE, the biologically active N-terminal region. The acetate form is given by intravenous infusion in the differential diagnosis of HYPOPARATHYROIDISM and PSEUDOHYPOPARATHYROIDISM. (Reynolds JEF(Ed): Martindale: The Extra Pharmacopoeia (electronic version). Micromedex, Inc, Englewood, CO, 1995)

Reduction of bone mass without alteration in the composition of bone, leading to fractures. Primary osteoporosis can be of two major types: postmenopausal osteoporosis (OSTEOPOROSIS, POSTMENOPAUSAL) and age-related or senile osteoporosis.

A nonhormonal medication for the treatment of postmenopausal osteoporosis in women. This drug builds healthy bone, restoring some of the bone loss as a result of osteoporosis.

Presence of air or gas in the subcutaneous tissues of the body.

The uptake of substances via the SUBCUTANEOUS TISSUE.

More From BioPortfolio on "A Study for the Transdermal Application of Teriparatide"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Dermatology
Acne Dermatology Eczema Psoriasis Wound Care Dermatology is the medical specialty concerned with the diagnosis and treatment of skin disorders (Oxford Medical Dictionary). As well as studying how the skin works, dermatology covers...

Wound management
Anything that breaks the skin is a wound because when the skin is broken, there's a risk of germs getting into the body and causing an infection. Follow and track Wound Care News on BioPortfolio: Wound Car...

Osteoporosis
Osteoporosis is a disease in which the bones become extremely porous, are subject to fracture, and heal slowly, occurring especially in women following menopause and often leading to curvature of the spine from vertebral collapse. Follow and track&n...


Searches Linking to this Trial