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Completed

NCT Number: NCT01348269

Assessment of Efficacy of Zoledronic Acid in the Treatment of Bone Marrow Edema Syndrome

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.

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Key information

Conditions

Bone Marrow Edema

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Department of trauma, hand, reconstructive and plastic, University of Wuerzburg, Würzburg, Bavaria, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 <50: additionally: FSH >40MIE/ml and estrogen deficiency of <30pg/ml or a negative estrogen test)
  • status post hysterectomy and / or bilateral oophorectomy
  • finished reproduction planning
  • secure diagnosis of bone marrow edema using MRT
  • current osteologic basic laboratory values (≤ 4 weeks before V2) according to DVO criteria
  • presence of an personally signed informed consent for the participation in the study

Exclusion criteria

  • - subchondral bone loss or already occurred cartilage damage due to the bone marrow edema
  • reactive bone marrow edema with advanced arthrotic changes in the adjacent joint (grade III and IV according to Kellgren and Lawrence)
  • patients with edematous changes in bone marrow due to the diagnosis of M. Sudeck / algodystrophy / Complex Regional Pain Syndrome (CRPS)
  • patients with known hypo- and hyperparathyroidism, osteogenesis imperfecta, osteomalacia, M. Paget or another systemic skeletal diseases, except osteoporosis
  • patients with bone necrosis in the painful skeletal region
  • patients with infectious process at the affected bone or the adjacent joint and adjacent soft parts, respectively
  • patients with diagnosed or assumed rheumatoid arthritis, Lupus erythematodes, collagenosis or vasculitides
  • patients with advanced renal insufficiency (GFR according to Cockcroft

/ Gault ≤ 40 ml/min/KO)

  • patients with malignant diseases with osseous manifestation in anamnesis/history
  • status post malignant basic/primary disease with large dosed chemotherapy
  • current or massive dose therapy completed before less than 6 weeks (>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

Treatment and study plan

Aclasta

Drug

1 x intravenous non-current drip (infusion)

Placebo

Drug

NaCl Solution

Primary outcomes

  1. Reduction of the Edema Area

    Time frame: Week 6 after administration of a single intravenous dose of zoledronic acid (5 mg)

    The volume of the edema in cm³ is defined as biometric data measured by the use of MRI before and six weeks after treatment. Edema volume at screening was set to 100%. Edema volume six weeks after study drug administration was provdied as percentage reduction compared to the value at screening

Secondary outcomes

  1. Reduction of Pain (VAS)

    Time frame: Assessment at week 3

    Reduction of pain as measured by a Visual Analog Scale (VAS). Range 0-100 with higher values indicating worse pain.

  2. Reduction of Pain

    Time frame: Assessment at week 6

    Reduction of pain as measured by a visual analog scale (VAS). Range 0-100. Higher values indicating worse pain.

  3. Quality of Life (Qualeffo-41 Questionnaire)

    Time frame: Assessment at week 3

    Quality of life as measured by the Qualeffo-41 questionnaire - a quality of life questionnaire in patients with fractures of the European Foundation for Osteoporosis Higher values indicate worse quality of life

  4. Quality of Life (Qualeffo-41 Questionnaire)

    Time frame: Assessment at week 6

    Quality of life as measured by the Qualeffo-41 questionnaire - a quality of life questionnaire in patients with vertebral fractures of the European Foundation for Osteoporosis

  5. Subjective Estimation of Medical Condition (PDI)

    Time frame: Assessment at week 3

    Subjective estimation of medical condition as assessed by PDI (Pain Disability Index). Range 0-70. The higher the index the greater the person's disability due to pain.

  6. Subjective Estimation of Medical Condition (PDI)

    Time frame: Assessment at week 6

    Subjective estimation of medical condition as assessed by PDI (Pain Disability Index)

  7. Number of Additional Medicinal Visits

    Time frame: Assessment at week 3

    Number of additional medicinal visits until week 3

  8. Number of Additional Medicinal Visits

    Time frame: Assessment at week 6

    Aggregated number of unscheduled medicinal visits

  9. Number of Days of Illness

    Time frame: Assessment at week 6

    Aggregated number of days of illness i.e. sick leave from work, assessed until week 6

  10. Number of Days of Illness

    Time frame: Assessment at week 6

    Number of days of illness assessed until week 6

  11. Number of Aseptic Bone Necrosis and Fatigue Fractures

    Time frame: Baseline until end of study (week 12)

    Assessment of number of patients withaseptic bone necrosis and/or fatigue fractures.

  12. Number of Participants With Adverse Events as a Measure of Safety and Tolerability

    Time frame: Week 3, 6

    including changes in the following parameters according to DVO guidelines: Calcium, Phosphate, Creatinin-Clearance (Cockcroft-Gault), Alkaline Phosphatase, γGT, CRP

Sponsors and collaborators

Lead sponsor

Wuerzburg University Hospital

Other

Collaborators

  • Crolll Gmbh
  • University of Wuerzburg

Registry information

Official study title

A Prospective, Bi-centric,Randomized, Primary Double-blind, Placebo-controlled Phase III Study to Assess the Efficacy of Zoledronic Acid in the Treatment of Bone Marrow Edema Syndrome

Acronym: ZoMARS

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
May 5, 2011
Registry last updated
Aug 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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