Table 1

Potential treatment effect modifiers

CharacteristicDescription
GenderMale vs female
Menopausal statusPremenopausal vs postmenopausal
Age (years)Continuous variable
Body mass index* (BMI)BMI ≥30 (obese) vs <30 (non-obese)
Radiographic osteoarthritis (OA) stageRadiographic minimum joint space width (continuous); Kellgren Lawrence grade
Baseline knee pain severityContinuous variable
Bone marrow lesion (BML)Presence of at least one moderate to large BML vs absence of presence of small BML
Baseline levels of systemic markers of bone turnover (eg, CTX-I, CTX-II and NTX-I)≥ mean value vs < mean value†
Systemic bone density statusEither as continuous variable or presence vs absence of osteopenia/osteoporosis
  • *Measured in kg m-2.

  • †Values will be standardised if the distribution is skewed.