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NCT03232476 Clinical Trial

Effect of Mechanical Loading With PTH on Cortical Bone

Osteoporosis, Postmenopausal Clinical Trial

Official title:
Effect of Mechanical Loading With PTH on Cortical Bone

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT03232476
Other study ID # 2017P001094
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received July 24, 2017
Last updated July 25, 2017
Start date September 2017
Est. completion date December 2019

Study information
Verified date July 2017
Source Massachusetts General Hospital
Contact Natalie David, BA
Phone 617-726-6129
Email ndavid2@mgh.harvard.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Clinical trial to investigate effect of voluntary upper extremity loading in combination with anabolic osteoporosis therapy.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 18
Est. completion date December 2019
Est. primary completion date December 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 45 Years and older
Eligibility Inclusion Criteria:

- women aged 45+

- postmenopausal

- osteoporotic with high risk of fracture

Exclusion Criteria:

- no significant previous use of bone health modifying treatments

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Upper extremity voluntary loading
Subjects who are prescribed teriparatide by their healthcare provider may enroll in this study. The study intervention consists of loading one upper extremity. Subjects will be trained on how to perform the upper extremity exercises at home. Subjects will be expected to perform the exercises 3 days per week using one arm, with each session consisting of 100 loading cycles lasting a total of approximately 2 minutes each day.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Massachusetts General Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary radius bone mineral density 12 month change
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