NCT03232476

Brief Summary

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

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2017

Typical duration for phase_4

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2017

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

July 24, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 28, 2017

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

November 25, 2025

Status Verified

November 1, 2025

Enrollment Period

2.4 years

First QC Date

July 24, 2017

Last Update Submit

November 20, 2025

Conditions

Osteoporosis, Postmenopausal

Outcome Measures

Primary Outcomes (1)

  • radius bone mineral density

    12 month change

Study Arms (1)

Loaded upper extremity

OTHER

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

Interventions

Upper extremity voluntary loadingDEVICE

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.

Loaded upper extremity

Eligibility Criteria

Age45 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • no significant previous use of bone health modifying treatments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoporosis, Postmenopausal

Condition Hierarchy (Ancestors)

OsteoporosisBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Joy Tsai, MD

    MGH

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 24, 2017

First Posted

July 28, 2017

Study Start

July 1, 2017

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

November 25, 2025

Record last verified: 2025-11