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Case contributed by Dr. Pan Chee Huan, Consultant Orthopaedic Surgeon, Kedah Medical Centre, Malaysia

Patient Information

Age: 76 years

Sex: Female

Underlying diseases: Hypertension

Other relevant patient demographics:

  • Housewife
  • BMI: 25.4
  • History

    Presenting complaint

    Low back pain

    • Sudden onset of low back pain after carrying heavy objects 4 months ago
    • Have to walk with support using walking stick
    • Duration: 4 months
    • FRAX score for Major Osteoporotic Fracture: 36%
    • FRAX score for Hip Fracture: 18%

    Past medical history

    • Hypertension
  • Physical examination
    • Low back: tenderness over the spinous processes of thoracolumbar spine and paraspinal region.
    • MRI of Lumbosacral spine Images: T2 and T2 Stir

    Findings

    • Acute compression fracture of Lumbar spine L2
    • Acute bone marrow oedema of Lumbar spine L3, L4 vertebrae
    • Old compression fracture of Thoracic spine T12
  • Investigation

    Bone metabolism studies

    Bone metabolism studies
    • All within normal limits

    1st DXA Scan (Before Romosozumab treatment)

    1st DXA Scan (Before Romosozumab treatment)
    1st DXA Scan (Before Romosozumab treatment)
    1st DXA Scan (Before Romosozumab treatment)

    2nd DXA Scan (1 year after romosozumab treatment)

    2nd DXA Scan (1 year after romosozumab treatment)
    2nd DXA Scan (1 year after romosozumab treatment)
    2nd DXA Scan (1 year after romosozumab treatment)

    Hologic Horizon W

    • LSC AP Spine 0.022 g/cm2
    • LSC Neck of Femur 0.028 g/cm2
    • LSC Total Hip 0.027 g/cm2

    Changes in BMD after completing 1 year of Romosozumab

    • Lumbar Spine = +0.121 g/cm2 (22.04%)
    • Neck of Femur = +0.03 g/cm2 (6.86%)
    • Total Hip = +0.049 g/cm2 (7.98%)
  • Treatment

    Non-pharmacological

    • Calcium supplement
    • Vitamin D supplement

    Pharmacological

    • Subcutaneous Romosozumab 210 mg monthly for 1 year

    Non-operative treatment

    • Lumbar Support
  • Follow-up

    Disease progression

    • The patient’s low back pain reduced 1 month, much reduced 2 months post-Romosozumab and resolved 4 months post-Romosozumab*.
    • She was able to walk without support 3 months post-Romosozumab.

    * Romosozumab is not indicated for treatment of back pain.

    Trend of investigation parameters

    There was an increase in the BMD after she underwent 1 year of treatment with Romosozumab:

    • Lumbar Spine: +0.121 g/cm2 (22.04%, LSC 0.022)
    • Neck of Femur: +0.03 g/cm2 (6.86%, LSC 0.028)
    • Total Hip: +0.049 g/cm2 (7.98%, LSC 0.027)

    All the increases in these three parameters were higher than the respective LSC.

    Additional information

    • After completion of 1 year of Romosozumab treatment, the patient was continued on subcutaneous Denosumab 60 mg 6-monthly treatment.
    • Currently she has completed 1 dose of Denosumab.
  • Clinical considerations

    Selection of Romosozumab as Anabolic Agent

    • Patient is in the Very High Fracture Risk group, requiring rapid gain in BMD
      • Prior osteoporotic fracture with multiple vertebrae fractures
      • T-score ≤ -3.5 (lumbar spine and neck of femur)
      • FRAX score major osteoporotic fracture of 36% and hip fracture of 18%
    • Romosozumab is not contraindicated1,2
      • No history of myocardial infarction, stroke or pre-existing hypocalcemia:
    • Monthly dosing of Romosozumab and the need to administer in a specialist clinic improves compliance3

    Selection of Denosumab as follow-up antiresorptive after 1 year of Romosozumab

    • Studies support the switch to Denosumab after anabolic therapy as it can achieve greater BMD increases at the spine and hip compared to switching to bisphosphonates4,5
  • Summary
    • Patient experienced sudden onset of low back pain after carrying heavy objects 4 months ago.
    • After physical examination with MRI, patient was found to have:
      • Acute compression fracture of Lumbar spine L2.
      • Acute bone marrow oedema of Lumbar spine L3, L4 vertebrae.
      • Old compression fracture of Thoracic spine T12.
    • DXA scan showed that the changes in BMD after completing 1 year of romosuzumab was:
      • Lumbar Spine = +0.121 g/cm2 (22.04%)
      • Neck of Femur = +0.03 g/cm2 (6.86%)
      • Total Hip = +0.049 g/cm2 (7.98%)
    • Patient was treated with vitamin D, calcium, subcutaneous Romosozumab 210 mg monthly and lumbar support
    • After completion of 1-year romosozumab treatment, the patient was continued on subcutaneous Denosumab 60 mg 6-monthly treatment.

  • Abbreviations

    AP, anteroposterior; BMD, bone mineral density; BMI, body mass index; DXA, dual-energy X-ray absorptiometry; FRAX, fracture risk assessment tool; LSC, least significant change; MRI, magnetic resonance imaging; SGOT/AST, serum glutamic-oxaloacetic transaminase/aspartate aminotransferase; SGPT/ALT, serum glutamic pyruvic transaminase/alanine aminotransferase; TSH, thyroid-stimulating hormone; T4, thyroxine

    References

    1. Saag KG, et al. N Engl J Med. 2017;377(15):1417-1427. doi:10.1056/NEJMoa1708322

    2. Malaysia local pack insert for Romosozumab. Full prescribing information.

    3. Kosaka Y, et al. Tohoku J Exp Med. 2021;255(2):147-155. doi:10.1620/tjem.255.147

    4. Kendler DL, et al. Adv Ther. 2022;39(1):58-74. doi:10.1007/s12325-021-01936-y

    5. Leder BZ. JBMR Plus. 2018;2(2):62-68. Published 2018 Feb 27. doi:10.1002/jbm4.10041

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