Phase 3
N=48
Assessment of Efficacy of Zoledronic Acid in the Treatment of Bone Marrow Edema Syndrome
Bone Marrow Edema
Bottom Line
View on ClinicalTrials.gov: NCT01348269 ↗Enrolled (actual)
48
Serious AEs
10.4%
Results posted
Aug 2024
Primary outcome: Primary: Reduction of the Edema Area — 64.53; 23.97 percentage of edema volume — p==0.006
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Aclasta (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Wuerzburg University Hospital
- Primary completion
- Aug 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Reduction of the Edema Area |
64.53; 23.97 | =0.006 sig |
| SECONDARY Reduction of Pain (VAS) |
25.5; 25.6 | — |
| SECONDARY Reduction of Pain |
25.0; 38.5 | — |
| SECONDARY Quality of Life (Qualeffo-41 Questionnaire) |
2.0; 2.1 | — |
| SECONDARY Quality of Life (Qualeffo-41 Questionnaire) |
2.0; 2.1 | — |
| SECONDARY Subjective Estimation of Medical Condition (PDI) |
13.1; 18.8 | — |
| SECONDARY Subjective Estimation of Medical Condition (PDI) |
13.1; 18.8 | — |
| SECONDARY Number of Additional Medicinal Visits |
0; 0 | — |
| SECONDARY Number of Additional Medicinal Visits |
0; 0 | — |
| SECONDARY Number of Days of Illness |
0.94; 3.14 | — |
| SECONDARY Number of Days of Illness |
0.94; 3.14 | — |
| SECONDARY Number of Aseptic Bone Necrosis and Fatigue Fractures |
0; 0 | — |
| SECONDARY Number of Participants With Adverse Events as a Measure of Safety and Tolerability |
0; 0; 0; 0; 0; 0 | — |
Summary
The primary aim is to test the reduction of bone marrow edema syndrome after a singular intravenous treatment with Zoledronic Acid within 6 weeks compared to placebo. The volume of the edema is defined as biometric data measured by the use of MRT before and six weeks after treatment. The hypothesis has to be checked whether Zoledronic Acid is efficient in the treatment of painful bone marrow edema. A statistically significant reduction of the edema in the MRT is considered as evidence for efficacy.
Eligibility Criteria
Inclusion Criteria
- Men: age over ≥ 18 years or women: age over ≥ 18 years with finished reproductivity according to the following definition:
- ≥ 12 month persistent natural (spontaneous) amenorrhoea (women aged 40MIE/ml and estrogen deficiency of 7.5mg prednisolon equivalent) with glucocorticoids
- patients with a malignant tumor disease within the past 5 years, independent from the affected organ system and independent from the implemented treatment, the presence of a relapse or metastatic invasion, except basal cell carcinoma and squamous-cell carcinoma of the skin Current treatment due to uveitis
- vague/ambiguous hyper- or hypocalcemia, hyper- or hypophosphatemia
- etiological vague/ambiguous AP-increase
- symptomatic renal calculus or nephrocalcinosis within 2 years before V2
- recent fracture within the last 3 months independent of the localisation
- non consolidated fractures
- previous treatment with i.v. bisphosphonates within the last 12 months
- previous treatment with oral bisphosphonates within the last 12 months and longer than 3 months
- pre-treatment with prostacyclin analogs (Ilomedin® / Iloprost®) within the past 6 months
- Current treatment due to inflammatory diseases of the jaw area as well as planned tooth extractions or tooth extractions less than 6 months ago or oral surgery implant treatment
- pregnancy or nursing period
- patients immediately involved in the conduction of the trial and relatives
- patients with current proceedings related to the bone marrow edema
- patients for which the participation in the study carries an increased risk under consideration of the health condition due to the assessment of the investigator
- participation in another clinical trial within 30 days before study start or during the trial
- participation of patient who might be dependent on the investigator, also the spouse, parents or children
Data sourced from ClinicalTrials.gov (NCT01348269). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.