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.

Timeline

Start

2015-11

Primary completion

2018-11

Completion

2019-11

Outcome

Mixed primary results

paper The primary endpoint, bone mineral density (BMD), will be measured by dual-energy x-ray absorptiometry of the total hip and the lumbar spine. PMID 29548300 ↗

paper The adjusted treatment effect of adding WBV to teriparatide was statistically significant at 2.95% [95% CI = 0.14-5.77; P = 0.040]. PMID 31309239 ↗

paper No other treatment effects were observed in hip BMD, bone microarchitecture parameters, or sclerostin levels in either group. PMID 31309239 ↗

Publications

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• Background Hazell TJ, Kenno KA, Jakobi JM. Evaluation of muscle activity for loaded and unloaded dynamic squats during vertical whole-body vibration. J Strength Cond Res. 2010 Jul;24(7):1860-5. doi: 10.1519/JSC.0b013e3181ddf6c8.
• Background Roelants M, Verschueren SM, Delecluse C, Levin O, Stijnen V. Whole-body-vibration-induced increase in leg muscle activity during different squat exercises. J Strength Cond Res. 2006 Feb;20(1):124-9. doi: 10.1519/R-16674.1.
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• Jepsen DB, Masud T, Holsgaard-Larsen A, Hansen S, Jorgensen NR, Ryg J. The combined effect of parathyroid hormone (1-34) and whole-body vibration exercise on physical performance in OSteoporotic women (PaVOS study): a secondary analysis from a randomised controlled trial. BMC Sports Sci Med Rehabil. 2020 Sep 5;12:54. doi: 10.1186/s13102-020-00204-w. eCollection 2020.
• Jepsen DB, Ryg J, Hansen S, Jorgensen NR, Gram J, Masud T. The combined effect of Parathyroid hormone (1-34) and whole-body Vibration exercise in the treatment of postmenopausal OSteoporosis (PaVOS study): a randomized controlled trial. Osteoporos Int. 2019 Sep;30(9):1827-1836. doi: 10.1007/s00198-019-05029-z. Epub 2019 Jul 15.
• Jepsen DB, Ryg J, Jorgensen NR, Hansen S, Masud T. 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. Trials. 2018 Mar 16;19(1):186. doi: 10.1186/s13063-018-2551-5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Teriparatide	Protein / enzyme biologic	20 ug	Subcutaneous

Indications