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Effect of Mechanical Loading With PTH on Cortical Bone

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03232476
Recruitment Status : Not yet recruiting
First Posted : July 28, 2017
Last Update Posted : July 28, 2017
Information provided by (Responsible Party):
Joy Tsai, Massachusetts General Hospital

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

Condition or disease Intervention/treatment Phase
Osteoporosis, Postmenopausal Device: Upper extremity voluntary loading Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Effect of Mechanical Loading With PTH on Cortical Bone
Estimated Study Start Date : September 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis

Arm Intervention/treatment
Loaded upper extremity
This is a one-arm study. In postmenopausal women prescribed teriparatide for osteoporosis treatment, enrolled subjects will perform voluntary loading exercises on one upper extremity. A data logger device will assist in recording exercises and determining goal force during the exercises. Each subject's non-loaded upper extremity will serve as a control.
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.

Primary Outcome Measures :
  1. radius bone mineral density [ Time Frame: 12 month change ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • women aged 45+
  • postmenopausal
  • osteoporotic with high risk of fracture

Exclusion Criteria:

  • no significant previous use of bone health modifying treatments

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03232476

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Contact: Natalie David, BA 617-726-6129

Sponsors and Collaborators
Massachusetts General Hospital
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Principal Investigator: Joy Tsai, MD MGH

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Responsible Party: Joy Tsai, Principal Investigator, Massachusetts General Hospital Identifier: NCT03232476     History of Changes
Other Study ID Numbers: 2017P001094
First Posted: July 28, 2017    Key Record Dates
Last Update Posted: July 28, 2017
Last Verified: July 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents