ACTIVE_NOT_RECRUITING

Romosozumab Use to Build Skeletal Integrity

Conditions

Osteoporosis Osteoporosis, Postmenopausal Osteoporosis Fracture Bone loss Nursing Home Patients Long-term Care Patients Osteoporotic Fractures

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to find out if one year of romosozumab (Evenity®), a monthly injection given in the arm under the skin, prior to an infusion of zoledronic acid Reclast®, works to treat bone loss and prevent it from worsening in older women (ages 65 and older) who have osteoporosis and reside in long-term care (LTC) facilities.

Official Title

Innovative Approach to Geriatric Osteoporosis

Quick Facts

Study Start:2021-09-15

Study Completion:2027-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05058976

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:65 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* They reside in an institution (nursing home or assisted living facility or senior care community); * They have a) osteoporosis by axial bone density (spine, hip or forearm BMD T-score≤ -2.5 SD), b) a previous adult fragility fracture of the spine or hip or c) would be treated based on FRAX and the National Osteoporosis Foundation (NOF) treatment thresholds of a 10 year risk of 10% for a major osteoporotic fracture or ≥ 3% for hip fracture using femoral neck BMD. * Willing and able to complete the informed consent process or provide consent by proxy.	* Those with subacute illnesses who are not expected to survive or who will be discharged in less than 2 years. * Those who have previously had an acute cardiovascular or cerebrovascular event within the preceding year. specifically, no recent history of coronary heart disease, heart failure, significant arrhythmia, stroke or Transient Ischemic Attack (TIA). * Recent cardiovascular disease (CVD) symptoms (significant chest pain, congestive heart failure, shortness of breath, or palpitations or cerebrovascular symptoms such as numbness or weakness in the face, arm, legs, difficulty talking, changes in vision, loss of balance, headache, feeling light-headed or dizzy). * Unstable angina. * Those who are currently on therapy (including a bisphosphonate, denosumab, teriparatide, abaloparatide or romosozumab) or have been on a bisphosphonate for greater than 1 year during the previous 2 years. * Those who are unable to take an intravenous bisphosphonate (zoledronic acid) due to renal insufficiency with eGFR \< 35 ml/min. * Vitamin D levels \<25 ng/mL. * Participants will be allowed to continue on medications known to affect bone and mineral metabolism (e.g., glucocorticoids, anticonvulsants) because their use is common in this population. * Those who have been treated in the past or present with osteoporosis agents, such as estrogen/progesterone or raloxifene will be allowed to participate and continue on these therapies if prescribed by their physician. * Patients will be allowed to wear hip pads if prescribed by their physician. * Non-ambulatory residents (those who cannot stand and pivot with assistance in order to transfer to the DXA table) will be excluded.

Inclusion Criteria

Exclusion Criteria

* They reside in an institution (nursing home or assisted living facility or senior care community);
* They have a) osteoporosis by axial bone density (spine, hip or forearm BMD T-score≤ -2.5 SD), b) a previous adult fragility fracture of the spine or hip or c) would be treated based on FRAX and the National Osteoporosis Foundation (NOF) treatment thresholds of a 10 year risk of 10% for a major osteoporotic fracture or ≥ 3% for hip fracture using femoral neck BMD.
* Willing and able to complete the informed consent process or provide consent by proxy.

* Those with subacute illnesses who are not expected to survive or who will be discharged in less than 2 years.
* Those who have previously had an acute cardiovascular or cerebrovascular event within the preceding year. specifically, no recent history of coronary heart disease, heart failure, significant arrhythmia, stroke or Transient Ischemic Attack (TIA).
* Recent cardiovascular disease (CVD) symptoms (significant chest pain, congestive heart failure, shortness of breath, or palpitations or cerebrovascular symptoms such as numbness or weakness in the face, arm, legs, difficulty talking, changes in vision, loss of balance, headache, feeling light-headed or dizzy).
* Unstable angina.
* Those who are currently on therapy (including a bisphosphonate, denosumab, teriparatide, abaloparatide or romosozumab) or have been on a bisphosphonate for greater than 1 year during the previous 2 years.
* Those who are unable to take an intravenous bisphosphonate (zoledronic acid) due to renal insufficiency with eGFR \< 35 ml/min.
* Vitamin D levels \<25 ng/mL.
* Participants will be allowed to continue on medications known to affect bone and mineral metabolism (e.g., glucocorticoids, anticonvulsants) because their use is common in this population.
* Those who have been treated in the past or present with osteoporosis agents, such as estrogen/progesterone or raloxifene will be allowed to participate and continue on these therapies if prescribed by their physician.
* Patients will be allowed to wear hip pads if prescribed by their physician.
* Non-ambulatory residents (those who cannot stand and pivot with assistance in order to transfer to the DXA table) will be excluded.

Contacts and Locations

Principal Investigator

Susan L Greenspan, MD

PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Study Locations (Sites)

UPMC Senior Communities

Pittsburgh, Pennsylvania, 15213

United States

Collaborators and Investigators

Sponsor: Susan L. Greenspan

Susan L Greenspan, MD, PRINCIPAL_INVESTIGATOR, University of Pittsburgh

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-09-15

Study Completion Date2027-09

Study Record Updates

Study Start Date2021-09-15

Study Completion Date2027-09

Terms related to this study

Keywords Provided by Researchers

Bone loss
Nursing Home Patients
Long-term Care Patients
Osteoporotic Fractures

Additional Relevant MeSH Terms

Osteoporosis
Osteoporosis, Postmenopausal
Osteoporosis Fracture