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Romosozumab Use to Build Skeletal Integrity (RUBI)

Primary Purpose

Osteoporosis, Osteoporosis, Postmenopausal, Osteoporosis Fracture

Status

Recruiting

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Romosozumab

Placebo

Zoledronic acid

Calcium and Vitamin D

About this trial

This is an interventional treatment trial for Osteoporosis focused on measuring Bone loss, Nursing Home Patients, Long-term Care Patients, Osteoporotic Fractures

Eligibility Criteria

65 Years - undefined (Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Elderly women 65 years and older will be considered if:

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.

Exclusion Criteria:

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.

Sites / Locations

UPMC Senior CommunitiesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Romosozumab, then Zoledronic Acid

Placebo, then Zoledronic Acid

Arm Description

Monthly dose: 210 mg Romosozumab subcutaneous injections; Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplements); all participants will receive 5 mg Zoledronic Acid IV infusion at the Month 12 visit.

Monthly dose: placebo saline subcutaneous injections; Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplements); all participants will receive 5 mg Zoledronic Acid IV infusion at the Month 12 visit.

Outcomes

Primary Outcome Measures

Bone Mineral Density of the total hip

Bone Mineral Density (BMD) of the total hip at 24 months as assessed by dual-energy x-ray absorptiometry (DXA)

Bone Mineral Density of the spine

Bone Mineral Density (BMD) of the spine at 24 months as assessed by dual-energy x-ray absorptiometry (DXA)

Secondary Outcome Measures

Full Information

NCT ID

NCT05058976

First Posted

September 17, 2021

Last Updated

September 8, 2023

Sponsor

Susan L. Greenspan

Collaborators

National Institutes of Health (NIH), National Institute on Aging (NIA)

1. Study Identification

Unique Protocol Identification Number

NCT05058976

Brief Title

Romosozumab Use to Build Skeletal Integrity

Acronym

RUBI

Official Title

Innovative Approach to Geriatric Osteoporosis

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 15, 2021 (Actual)

Primary Completion Date

September 2027 (Anticipated)

Study Completion Date

September 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Susan L. Greenspan

Collaborators

National Institutes of Health (NIH), National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

Detailed Description

Objective: The long-term goal of this study is to improve health, well-being and quality of life in the frail Long-term Care (LTC) population by reducing fractures. The short-term goal is to demonstrate efficacy of the novel dual action Romosozumab (ROMO) to improve Bone Mineral Density (BMD) and skeletal integrity and its safety, a necessary (but not sufficient) precondition of a large fracture reduction trial. The investigators propose to conduct a 2-year, randomized, double-blind, calcium vitamin D controlled trial to test the efficacy and safety of the sclerostin inhibitor ROMO among a cohort of 200 underserved, institutionalized, frail women ≥65 years old. Bone measures will be collected in a mobile lab. The monthly subcutaneous therapy negates concerns regarding poor oral absorption or compliance. The use of annual Zoledronic Acid (ZOL) to follow ROMO, will prevent bone loss and insure the entire group will be provided with at least 1 year of therapy. The groups include: 1) ROMO →ZOL vs 2) placebo →ZOL. Aim 1: Evaluate efficacy of bone building ROMO treatment prior to ZOL in improving bone mineral density. H1: Women on ROMO →ZOL will have greater hip and spine BMD increases after 2 years (H1.1-primary) and 1 year (H1.2), and at other locations (H1.3). Aim 2: Examine improvements in 3D trabecular microstructure (TBS), markers of bone turnover and collect preliminary evidence for a fracture reduction trial. The investigators will measure vertebral trabecular bone score (TBS), a 3-D microarchitectural image and parameters of the spine, hip, and lateral spine H2: Women on ROMO →ZOL will have greater increases in TBS measures of spine, hip and lateral spine after one (H2.1) and two (H2.2) years; and improvement in bone turnover markers (CTx and P1NP; H2.3). Aim 3: Determine characteristics associated with responders and non responders. The investigators will use multiple regression analyses and other data mining techniques to identify baseline characteristics of responders and non-responders. H3.1: Poor baseline functional/cognitive status/immobility will be associated with poor bone healthy outcomes. H3.2: Greater early changes in bone turnover markers will be associated with greater skeletal improvements.

6. Conditions and Keywords

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

Osteoporosis, Osteoporosis, Postmenopausal, Osteoporosis Fracture

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Romosozumab, then Zoledronic Acid

Arm Type

Experimental

Arm Description

Arm Title

Placebo, then Zoledronic Acid

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Romosozumab

Other Intervention Name(s)

Evenity

Intervention Description

Monthly dose: 210 mg subcutaneous injection

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Monthly saline injection

Intervention Type

Drug

Intervention Name(s)

Zoledronic acid

Other Intervention Name(s)

Reclast

Intervention Description

5 mg IV infusion at Month 12 Visit

Intervention Type

Dietary Supplement

Intervention Name(s)

Calcium and Vitamin D

Intervention Description

Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement)

Primary Outcome Measure Information:

Title

Bone Mineral Density of the total hip

Description

Bone Mineral Density (BMD) of the total hip at 24 months as assessed by dual-energy x-ray absorptiometry (DXA)

Time Frame

24 months

Title

Bone Mineral Density of the spine

Description

Bone Mineral Density (BMD) of the spine at 24 months as assessed by dual-energy x-ray absorptiometry (DXA)

Time Frame

24 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Elderly women 65 years and older will be considered if: 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. Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Cristie Porco, RN

Phone

412-692-2483

clp98@pitt.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Bari M Guzikowski, BA

Phone

412-436-9190

bmg96@pitt.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Susan L Greenspan, MD

Organizational Affiliation

University of Pittsburgh

Official's Role

Principal Investigator

Facility Information:

Facility Name

UPMC Senior Communities

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15213

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Cristie Porco, RN

Phone

412-692-2483

clp98@pitt.edu

First Name & Middle Initial & Last Name & Degree

Bari M Guzikowski, BA

Phone

4124369190

bmg96@pitt.edu

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Data to be shared will include all IPD collected, with the exception of essential identifying information.

IPD Sharing Time Frame

Any data request will be considered only after main planned manuscripts have been accepted for publication.

IPD Sharing Access Criteria

The PI and the investigative team will review data requests. If approved, all essential identifying information will be removed prior to data distribution. When a request of the data is received, a data sharing agreement will be sent to the requestor which will specifically include requirements for privacy and confidentiality, especially that no attempt will be made to identify study participants, that the data will not be redistributed, and will be destroyed after completing the specific stated purpose. Upon receipt of the signed data sharing agreement, the PI will send the distribution file to the requestor using an appropriate modality such as email or cloud storage.

Learn more about this trial

Romosozumab Use to Build Skeletal Integrity

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