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Denosumab to Prevent High-Turnover Bone Loss After Bariatric Surgery

Primary Purpose

Bariatric Surgery Candidate, Bone Loss

Status

Active

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Denosumab

Placebo

Zoledronic Acid

About this trial

This is an interventional prevention trial for Bariatric Surgery Candidate

Eligibility Criteria

25 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

Postmenopausal women who are planning RYGB or SG surgery
Men aged ≥ 50 years who are planning RYGB or SG surgery

Exclusion criteria:

Prior bariatric surgery
Weight = 400 lbs (due to limitations of bone imaging equipment)
Renal disease
Hypercalcemia or hypocalcemia
Hypomagnesemia
Serum 25-OH vitamin D (25OHD) < 20 ng/mL
Hyperparathyroidism
Liver disease (AST or ALT > 2 x upper normal limit)
HCT < 32%
History of malignancy (except basal cell carcinoma) in the past 1 year
Significant cardiopulmonary disease
Major psychiatric disease
History of celiac disease or inflammatory bowel disease
Excessive alcohol or substance abuse
Paget's disease, primary hyperparathyroidism, or any other known congenital or acquired bone disease other than osteoporosis
Current hyperthyroidism or use of levothyroxine with TSH < 0.1 uIU/mL
Current use of loop diuretics
Current use or use in the past 12 months of oral bisphosphonates or DMAB
Current use or use within the past 3 months of SERMs or calcitonin
Current use or use within the past 3 months of estrogen
Use of testosterone therapy if dose has changed within the last 3 months, or if dose change or discontinuation is planned in the upcoming 18 months
Any current or previous use of teriparatide, strontium, or any parenteral bisphosphonate
Use of oral or parenteral glucocorticoids for more than 14 days within the past 6 months
Extensive dental work involving extraction or dental implant within the past 2 months or planned in the upcoming 18 months
DXA BMD T-score of < -3.0 at PA spine, total hip, or femoral neck
Current use of anti-VEGF drug

Sites / Locations

University of California, San Francisco
Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Denosumab

Placebo

Arm Description

Denosumab 60mg subcutaneous injection every 6 months

Placebo subcutaneous injection every 6 months

Outcomes

Primary Outcome Measures

Percentage change in total hip bone mineral density

Secondary Outcome Measures

Full Information

NCT ID

NCT04087096

First Posted

September 10, 2019

Last Updated

October 17, 2023

Sponsor

Massachusetts General Hospital

Collaborators

University of California, San Francisco, San Francisco VA Health Care System

1. Study Identification

Unique Protocol Identification Number

NCT04087096

Brief Title

Denosumab to Prevent High-Turnover Bone Loss After Bariatric Surgery

Official Title

Denosumab to Prevent High-Turnover Bone Loss After Bariatric Surgery

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

August 24, 2020 (Actual)

Primary Completion Date

August 2024 (Anticipated)

Study Completion Date

August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Massachusetts General Hospital

Collaborators

University of California, San Francisco, San Francisco VA Health Care System

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

Bariatric surgery leads to bone loss and increases fracture risk. This study evaluates whether denosumab can prevent the high-turnover bone loss that occurs after Roux-en-Y Gastric Bypass (RYGB) and sleeve gastrectomy (SG) surgery.

Detailed Description

Bariatric surgery is a highly effective weight loss treatment, but one of the unintended side effects of these procedures is high-turnover bone loss and metabolic bone disease. Denosumab is a monoclonal antibody to RANKL that acts as a potent inhibitor of bone resorption. The investigators are conducting a randomized placebo-controlled trial to evaluate the ability of denosumab to prevent bone loss after RYGB or SG surgery in older adults. At the conclusion of the study, all participants will be given zoledronic acid.

6. Conditions and Keywords

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

Bariatric Surgery Candidate, Bone Loss

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Denosumab

Arm Type

Experimental

Arm Description

Denosumab 60mg subcutaneous injection every 6 months

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo subcutaneous injection every 6 months

Intervention Type

Drug

Intervention Name(s)

Denosumab

Other Intervention Name(s)

Prolia

Intervention Description

Denosumab will be administered at postoperative months 1, 7, and 13

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo will be administered at postoperative months 1, 7, and 13

Intervention Type

Drug

Intervention Name(s)

Zoledronic Acid

Other Intervention Name(s)

Reclast

Intervention Description

Zoledronic Acid 5mg will be administered intravenously at postoperative month 19

Primary Outcome Measure Information:

Title

Percentage change in total hip bone mineral density

Time Frame

Pre-operative baseline to post-operative month 19

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: Postmenopausal women who are planning RYGB or SG surgery Men aged ≥ 50 years who are planning RYGB or SG surgery Exclusion criteria: Prior bariatric surgery Weight = 400 lbs (due to limitations of bone imaging equipment) Renal disease Hypercalcemia or hypocalcemia Hypomagnesemia Serum 25-OH vitamin D (25OHD) < 20 ng/mL Hyperparathyroidism Liver disease (AST or ALT > 2 x upper normal limit) HCT < 32% History of malignancy (except basal cell carcinoma) in the past 1 year Significant cardiopulmonary disease Major psychiatric disease History of celiac disease or inflammatory bowel disease Excessive alcohol or substance abuse Paget's disease, primary hyperparathyroidism, or any other known congenital or acquired bone disease other than osteoporosis Current hyperthyroidism or use of levothyroxine with TSH < 0.1 uIU/mL Current use of loop diuretics Current use or use in the past 12 months of oral bisphosphonates or DMAB Current use or use within the past 3 months of SERMs or calcitonin Current use or use within the past 3 months of estrogen Use of testosterone therapy if dose has changed within the last 3 months, or if dose change or discontinuation is planned in the upcoming 18 months Any current or previous use of teriparatide, strontium, or any parenteral bisphosphonate Use of oral or parenteral glucocorticoids for more than 14 days within the past 6 months Extensive dental work involving extraction or dental implant within the past 2 months or planned in the upcoming 18 months DXA BMD T-score of < -3.0 at PA spine, total hip, or femoral neck Current use of anti-VEGF drug

Facility Information:

Facility Name

University of California, San Francisco

City

San Francisco

State/Province

California

ZIP/Postal Code

94143

Country

United States

Facility Name

Massachusetts General Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

30219833

Citation

Lindeman KG, Greenblatt LB, Rourke C, Bouxsein ML, Finkelstein JS, Yu EW. Longitudinal 5-Year Evaluation of Bone Density and Microarchitecture After Roux-en-Y Gastric Bypass Surgery. J Clin Endocrinol Metab. 2018 Nov 1;103(11):4104-4112. doi: 10.1210/jc.2018-01496.

Results Reference

background

PubMed Identifier

31090893

Citation

Yu EW, Kim SC, Sturgeon DJ, Lindeman KG, Weissman JS. Fracture Risk After Roux-en-Y Gastric Bypass vs Adjustable Gastric Banding Among Medicare Beneficiaries. JAMA Surg. 2019 Aug 1;154(8):746-753. doi: 10.1001/jamasurg.2019.1157.

Results Reference

background

PubMed Identifier

29281126

Citation

Schafer AL, Kazakia GJ, Vittinghoff E, Stewart L, Rogers SJ, Kim TY, Carter JT, Posselt AM, Pasco C, Shoback DM, Black DM. Effects of Gastric Bypass Surgery on Bone Mass and Microarchitecture Occur Early and Particularly Impact Postmenopausal Women. J Bone Miner Res. 2018 Jun;33(6):975-986. doi: 10.1002/jbmr.3371. Epub 2018 Feb 5.

Results Reference

background

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Denosumab to Prevent High-Turnover Bone Loss After Bariatric Surgery

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