Treatment of Atraumatic Bone Marrow Edema With Denosumab and Teriparatide vs Placebo

NCT01734824 | Suspended Phase 4 DMC

• 2 other identifiers: Vinforce-012Bone marrow edema
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The etiology of bone marrow edema (BME) is still uncertain. Several studies report therapeutic success with antiresorptive drugs. This study investigates antiresorptive and osteoanabolic drugs versus placebo in BME

Conditions

Bone Marrow Oedema Syndrome; High Turnover Bone Disease; Quality of Life

Keywords

bone marrow edema, denosumab, PTH 1-84

Outcome Measures

Primary Outcomes (1)

• Reduction/termination of bone marrow edema with antiresorptive and osteoanabolic drugs

  MRI examination, fasting serum levels of bone turnover markers, QoL-questionnaire, VAS score

  baseline - month 1 - month 3

Study Arms (4)

Teriparatide

ACTIVE COMPARATOR

daily subcutaneous injection of teriparatide 20µg for three months

Drug: Teriparatide

Placebo Teriparatide

PLACEBO COMPARATOR

daily subcutaneous teriparatide placebo injection

Drug: Placebo Teriparatide

Denosumab

ACTIVE COMPARATOR

one subcutaneous injection of denosumab

Drug: Denosumab

Placebo Denosumab

ACTIVE COMPARATOR

one subcutaneous injection of denosumab placebo

Drug: Placebo Denosumab

Interventions

Denosumab DRUG

sc RANKL-inhibitor

Also known as: Prolia

Denosumab

Teriparatide DRUG

daily subcutaneous injection of teriparatide

Also known as: PTH 1-34

Teriparatide

Placebo Denosumab DRUG

one subcutaneous injection denosumab placebo

Also known as: Prolia

Placebo Denosumab

Placebo Teriparatide DRUG

daily subcutaneous placebo injection

Also known as: PTH 1-34

Placebo Teriparatide

Eligibility Criteria

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

You may qualify if:

• MRI diagnosed bone marrow edema

You may not qualify if:

• any prior antiresorptive or osteoanabolic treatment
• any prior therapy with strontium ranelate
• Hyper-/hypocalcemia
• malignancies
• pregnancy
• and contraindication against denosumab or teriparatide

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University Vienna - St. Vincent Hospital

Vienna, Vienna, 1060, Austria

Location

MeSH Terms

Interventions

Denosumab; Teriparatide; Parathyroid Hormone

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides

Study Officials

• Christian Muschitz, MD

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 2, 2012
• First Posted: November 28, 2012
• Study Start: May 1, 2012
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: September 23, 2015

Record last verified: 2015-09

Locations

AU (1)