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Published in: Trials 1/2018

Open Access 01-12-2018 | Study protocol

The combined effect of Parathyroid hormone (1-34) and whole-body Vibration exercise in the treatment of OSteoporosis (PaVOS)- study protocol for a randomized controlled trial

Authors: Ditte Beck Jepsen, Jesper Ryg, Niklas Rye Jørgensen, Stinus Hansen, Tahir Masud

Published in: Trials | Issue 1/2018

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Abstract

Background

PaVOS is a randomized controlled trial (RCT) which aims to address the use of whole-body vibration exercise (WBV) in combination with parathyroid hormone 1-34 fragment teriparatide (PTH 1-34) treatment in patients with osteoporosis. PTH 1-34 is an effective but expensive anabolic treatment for osteoporosis. WBV has been found to stimulate muscle and bone growth. Animal studies have shown a beneficial effect on bone when combining PTH 1-34 with mechanical loading. A combined treatment with PTH 1-34 and WBV may potentially have beneficial effects on bone and muscles, and reduce fracture risk.

Methods/design

PaVOS is a multicenter, assessor-blinded, superiority, two-armed randomized controlled trial (RCT).
Postmenopausal women (n = 40, aged 50 years and older) starting taking PTH 1-34 from outpatient clinics will be randomized and assigned to a PTH 1-34 + WBV-exercise group (intervention group), or a PTH 1-34-alone group (control group).
The intervention group will undergo WBV three sessions a week (12 min each, including 1:1 ratio of exercise: rest, 30 Hz, 1 mm amplitude) for a 12-month intervention period. Both the intervention and the control group will receive PTH 1-34 treatment (20 μg s.c. daily) for 24 months. After 12 months the WBV group will be re-randomized to stop or continue WBV for an additional 12 months.
The primary endpoint, bone mineral density (BMD), will be measured by dual-energy x-ray absorptiometry of the total hip and the lumbar spine.
Secondary endpoints, bone microarchitecture and estimated bone strength, will be assessed using high-resolution peripheral quantitative computed tomography (HR-pQCT) of the radius and tibia. Serum bone turnover markers (carboxy-terminal collagen crosslinks (CTX), amino-terminal propeptide of type-I collagen (P1NP), and sclerostin) and functional biomarkers (Timed Up and Go (TUG), Short Physical Performance Battery (SPPB), grip strength, and leg extension power) will be measured to assess the effect on bone turnover, muscle strength, balance, and functionality. Quality of life (EQ-5D), physical activity (IPAQ) and fear of falling (FES-I) will be assessed by questionnaires. Data on adherence and falls incidence will be collected.

Discussion

The PaVOS study will investigate the effects of WBV in combination with PTH 1-34 on bone parameters in postmenopausal women.

Trial registration

ClinicalTrials.gov, ID: NCT02563353. Registered on 30 September 2015.
Appendix
Available only for authorised users
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Metadata
Title
The combined effect of Parathyroid hormone (1-34) and whole-body Vibration exercise in the treatment of OSteoporosis (PaVOS)- study protocol for a randomized controlled trial
Authors
Ditte Beck Jepsen
Jesper Ryg
Niklas Rye Jørgensen
Stinus Hansen
Tahir Masud
Publication date
01-12-2018
Publisher
BioMed Central
Published in
Trials / Issue 1/2018
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-018-2551-5

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