NCT04275011: BRRIE

Bone Response to Exercise in Women on Antiresorptive Medications

Terminated NA Last updated 2 September 2022

What this trial tests

NA trial testing Progressive Resistance and Impact Exercise in Osteoporosis in 26 participants. Terminated before completion.

Timeline

2 January 2020

Primary endpoint
16 March 2020

16 March 2020

Quick facts

Lead sponsor	University of Waterloo
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	other
Enrollment	26
Start date	2 January 2020
Primary completion	16 March 2020
Estimated completion	16 March 2020
Sites	1 location across Canada

Drugs / interventions tested

• Progressive Resistance and Impact Exercise
• Static Balance and Postural Exercise

Conditions studied

• Osteoporosis — all drugs for Osteoporosis →
• Bone Loss — all drugs for Bone Loss →

Sponsor

University of Waterloo

Who can join

18 and older, female only, with Osteoporosis or Bone Loss. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Performing resistance training and impact exercise at a moderate to high intensity may help prevent bone loss. However, medications used to treat bone diseases such as osteoporosis reduce the activity of bone cells. The investigators are unsure whether bone cells will still respond to exercise in people on osteoporosis medications. Therefore, investigators have designed a study to compare bone response to moderate-high intensity exercise that involves resistance training and impact exercise versus posture and low intensity balance exercises. Women taking osteoporosis medication will be equally and randomly assigned to one of the exercise groups. There will be 23 participants per group and both exercise programs will be performed over a span of 6 months, twice weekly, for approximately 30-45 minutes per session. Investigators will measure sclerostin, a bone-related protein found in the blood, to see if there are any changes after 3 months of training. Higher levels of sclerostin may result in greater bone breakdown. It is expected that the moderate-high intensity exercise program will decrease sclerostin levels more than low intensity training. Further, changes in sclerostin levels during the 6-month exercise intervention will be explored. The effects of the exercise program on other bone markers in the blood, physical ability, and quality of life will be reported. The willingness of the participants to perform the exercise program and the safety of the exercises provided will also be assessed.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Bibliometric and visualized analysis of exercise and osteoporosis from 2002 to 2021.
   Li F, Xie W, Han Y, Li Z, et al · · 2022 · cited 8× · PMID 36569140 · DOI 10.3389/fmed.2022.944444