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Effect of Mechanical Loading With PTH on Cortical Bone

Primary Purpose

Osteoporosis, Postmenopausal

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Upper extremity voluntary loading
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Osteoporosis, Postmenopausal

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • no significant previous use of bone health modifying treatments

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Loaded upper extremity

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    radius bone mineral density

    Secondary Outcome Measures

    Full Information

    First Posted
    July 24, 2017
    Last Updated
    July 25, 2017
    Sponsor
    Massachusetts General Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03232476
    Brief Title
    Effect of Mechanical Loading With PTH on Cortical Bone
    Official Title
    Effect of Mechanical Loading With PTH on Cortical Bone
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 2017 (Anticipated)
    Primary Completion Date
    December 2019 (Anticipated)
    Study Completion Date
    December 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Massachusetts General Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoporosis, Postmenopausal

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    18 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Loaded upper extremity
    Arm Type
    Other
    Arm Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    Upper extremity voluntary loading
    Intervention Description
    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 Measure Information:
    Title
    radius bone mineral density
    Time Frame
    12 month change

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: women aged 45+ postmenopausal osteoporotic with high risk of fracture Exclusion Criteria: no significant previous use of bone health modifying treatments
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Natalie David, BA
    Phone
    617-726-6129
    Email
    ndavid2@mgh.harvard.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Joy Tsai, MD
    Organizational Affiliation
    MGH
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Effect of Mechanical Loading With PTH on Cortical Bone

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