Denosumab vs Alendronate After Vertebroplasty

NCT05662358 | Unknown DMC

• 1 other identifier: ShenzhenPH06
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Osteoporotic vertebral compression fracture (OVCF) patients had a proportion of secondary fractures after percutaneous vertebroplasty (PVP). Denosumab and alendronate is both effective to prevent bone loss for OVCF postmenopausal women. However, trial evidence comparing effect of denosumab vs zoledronate after PVP was unknown. The study aims to assess the efficiency of denosumab vs alendronate for OVCF patients bone mineral density (BMD), bone turnover markers (BTMs), secondary fracture and adverse events after PVP

Conditions

Denosumab Allergy

Outcome Measures

Primary Outcomes (6)

• Lumbar bone mineral density(BMD)

  Lumbar vertebral (L1 to L4, except the surgery segment) BMD were determined at baseline, 6 and 12 months via dual energy X-ray

  up to 12 months

• Total hip BMD

  Total hip BMD were determined at baseline, 6 and 12 months via dual-energy X-ray.

  up to 12 months

• Femoral neck BMD

  Femoral neck BMD were determined at baseline, 6 and 12 month via dual-energy X-ray

  up to 12 months

• Procollagen type 1 n-terminal propeptide (P1NP)

  Bone formation marker, P1NP were determined at baseline, 6 and 12 months after surgery.

  up to 12 months

• C-terminal cross-linked type 1 collagen terminal peptide (CTX)

  Bone resorption marker, CTX were determined at baseline, 6 and 12 months after surgery

  up to 12 months

• Visual analog scale (VAS) back

  The VAS score for back pain were determined at baseline, 6 and 12 month. Use a ruler about 10cm long, one side is marked with "0" and the other "10" respectively. A score of 0 indicates no pain, 10 indicates the most unbearable pain

  up to 12 months

Secondary Outcomes (5)

• The Roland-Morris Disability Questionnaire

  up to 12 month

• The QUALEFFO-31 Questionnaire

  up to 12 month

• The EQ-5D Questionnaire

  up to 12 month

• Secondary fracture rate

  up to 12 month

• Adverse events

  up to 12 month

Study Arms (2)

Denosumab

EXPERIMENTAL

1 ml (60 mg) of denosumab (Prolia; Amgen, Inc) subcutaneous injection plus intravenous placebo every 6 months

Drug: Denosumab; Drug: Placebo

alendronate

ACTIVE COMPARATOR

oral 70 mg alendronate sodium weekly.

Drug: Alendronate; Drug: Placebo

Interventions

Denosumab DRUG

1 ml (60 mg) of denosumab (Prolia; Amgen, Inc) subcutaneous injection

Also known as: Denosumab 6 month/subcutaneous

Denosumab

Alendronate DRUG

oral 70 mg alendronate sodium weekly plus subcutaneous placebo per 6 month.

Also known as: oral alendronate

alendronate

Placebo DRUG

oral placebo weekly

Denosumab; alendronate

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be age between 50 and 85 years old
• X-ray diagnosis of 1 or 2 segment vertebral compression fractures from T4 to L5
• Bone mineral density T value less than -1 via dual-energy X-ray
• A recent fracture history less than 6 weeks
• MRI show bone marrow edema of fractured vertebrae
• low back pain, local paravertebral tenderness

You may not qualify if:

• Must be able to have no intervertebral fissure
• Must be able to have no infection
• Must be able to have no malignancy
• Must be able to have no neurological dysfunction
• Must be able to have no previous use of anti-osteoporosis drugs
• Must be able to have no inability to perform magnetic resonance imaging
• Must be able to have no prior back open surgery
• Must be able to have no other established contraindications for elective surgery

Sponsors & Collaborators

• Shenzhen People's Hospital: lead

Study Sites (1)

Shenzhen People's Hospital

Shenzhen, Guangdong, 518000, China

RECRUITING

MeSH Terms

Interventions

Denosumab; Injections, Subcutaneous; Alendronate

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Injections; Drug Administration Routes; Drug Therapy; Therapeutics; Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals

Central Study Contacts

Hongyu Wang, Doctor

CONTACT

18241651300; wanghongyu790039663@126.com

Song Wang, Master

CONTACT

18085243269; 2362380008@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2022
• First Posted: December 22, 2022
• Study Start: January 3, 2021
• Primary Completion: September 20, 2023
• Study Completion: October 25, 2023
• Last Updated: February 21, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)