Teriparatide (Forsteo) Treatment in Postmenopausal Women: Mechanism of Action

Summary

Previously the approach to treatment of osteoporosis has been to use medications which prevent excessive resorption of bone. More recently medications that build up new bone, i.e. anabolic treatments, have been, and are being, developed. The investigators would like to develop a strategy for evaluating the effectiveness of anabolic therapies by studying a currently available therapy (teriparatide). This strategy could then be used to assess new anabolic treatments as they are developed for use in humans.

The aims of this study are 1) to fully describe the changes in bone turnover in response to teriparatide by biochemical marker type and by time; 2) to fully describe the changes in bone mineral density (BMD) in response to teriparatide by site, bone compartment and time.

If this study is able to identify an early response to treatment, then this will help speed up drug development in this area, by allowing the identification of promising new anabolic drugs and enabling us to understand their mechanism of action. This will benefit the investigators patients as the investigators will have a better understanding of how these drugs work.

Conditions

• Osteoporosis

Interventions

DRUG

Teriparatide

Teriparatide (Forsteo) 20 mcg subcutaneous injection once daily. Duration 104 weeks.

Sponsors & Collaborators

• National Institute for Health Research, United Kingdom

  collaborator OTHER_GOV

• Sheffield Teaching Hospitals NHS Foundation Trust

  lead OTHER

Principal Investigators

• Richard Eastell, MD, FRCP, FRCPath, FMedSci · University of Sheffield

• Jennifer Walsh, PhD MRCP · Sheffield Teaching Hospitals NHS Foundation Trust

• Eugene McCloskey, MD, FRCPI · University of Sheffield

• Nicola Peel, DM FRCP · Sheffield Teaching Hospitals NHS Foundation Trust

• Angela Rogers, BSc (Hons), PhD, MCSP · University of Sheffield

• Margaret Paggiosi, Bsc (Hons), PhD, MICR · Sheffield Teaching Hospitals NHS Foundation Trust

• Lang Yang, PhD CSci · University of Sheffield

• David Hughes, BMedSci MBChB PhD FRCPath · Sheffield Teaching Hospitals NHS Foundation Trust

• Mark Wilkinson, PhD, FRCS (Tr&Orth) · University of Sheffield

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Max Age

84 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-01-31

Primary Completion

2015-08-31

Completion

2015-08-31

Countries

• United Kingdom

Study Locations