PTH and Vibration in OSteoporosis Study

Summary

Objective:

This is a randomized controlled trial (RCT) in osteoporosis patients randomized to standard parathyroid hormone (PTH) treatment alone or to standard PTH treatment and Whole-body vibration (WBV). PTH is an effective but expensive anabolic treatment for osteoporosis. WBV stimulates muscles and bones. A combined treatment might have synergistic or additive beneficial effects on bone, reducing fracture risk making treatment more effective and cost-effective. A beneficial effect on muscles and thereby falls risk of WBV may improve fracture risk even further.

If the results of this pilot study are promising then a strong case can be made for a large multi-centre RCT using strong endpoints including fractures and falls.

Conditions

• Osteoporosis

Interventions

OTHER

whole-body vibration

Whole-body vibration on vibration platforms. 30-40 Hertz, from 2 mm (low) to 4 mm (high) amplitude, 1 minutes x 6 with 1 minute break between. 3 times a week.

DRUG

teriparatide

Teriparatide, 20 microgram/day. 24 months of treatment.

Sponsors & Collaborators

• University of Southern Denmark

  collaborator OTHER

• Copenhagen University Hospital, Denmark

  collaborator OTHER

• Esbjerg Hospital - University Hospital of Southern Denmark

  collaborator OTHER

• Sygehus Lillebaelt

  collaborator OTHER

• Odense Patient Data Explorative Network

  collaborator OTHER

• Region of Southern Denmark

  collaborator OTHER

• Odense University Hospital

  lead OTHER

Principal Investigators

• Lars Matzen, Clin.Ass.Pro · Odense University Hospital

• Ditte Jepsen, MD, ph.d. student · University of Southern Denmark

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

50 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-11-30

Primary Completion

2018-11-30

Completion

2019-11-30

Countries

• Denmark

Study Locations