PTH and Vibration in OSteoporosis Study

• Status: Completed
• Trial end date: 2019-11-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Odense University Hospital
• Collaborators: Copenhagen University Hospital, Denmark; Hospital of South West Denmark; Odense Patient Data Explorative Network; OPEN - Odense Patient data Explorative Network; Region of Southern Denmark; Sygehus Lillebaelt; University of Southern Denmark
• Treatments: Teriparatide

Criteria

Inclusion Criteria:

• Women starting PTH treatment for osteoporosis according to Danish Osteoporosis guidelines

Exclusion Criteria:

• Women currently taking oral glucocorticoids

• Women unable to give informed consent

• Women unable to stand for 2 minutes at a time on the vibration platform

• Women who have contraindications to WBV (e.g. joint prosthesis, pacemakers)