search
Back to results

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
Sponsored by
Susan L. Greenspan
About
Eligibility
Locations
Arms
Outcomes
Full info

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

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)
search

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
No
Product Manufactured in and Exported from the U.S.
No
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
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.
Arm Title
Placebo, then Zoledronic Acid
Arm Type
Placebo Comparator
Arm Description
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.
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
No
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
Email
clp98@pitt.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Bari M Guzikowski, BA
Phone
412-436-9190
Email
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
Email
clp98@pitt.edu
First Name & Middle Initial & Last Name & Degree
Bari M Guzikowski, BA
Phone
4124369190
Email
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

We'll reach out to this number within 24 hrs