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. 2021 Jul 7;2021(7):CD013424. doi: 10.1002/14651858.CD013424.pub2

ACTIVE 2016.

Study characteristics
Methods
  • Study design: parallel RCT

  • Time frame: March 2011 to October 2014

  • Duration of study follow‐up: 19 months (18 months of treatment plus 1 month of follow‐up)

Participants
  • Country: multinational (Argentina, Brazil, China, Czech Republic, Denmark, Estonia, Lithuania, Poland, Romania, USA)

  • Setting: multicentre (28 sites)

  • Inclusion criteria: postmenopausal women; CKD stage 3; osteoporosis or past fracture and osteopenia; normal bone markers

  • Number: total (527); treatment group (168); control group 1 (167); control group 2 (192)

  • Mean age ± SD: 74.0 ± 5.5 years

  • Sex: women only

  • CKD stage: CKD stages 3‐4 (eGFR < 60 mL/min)

  • BMI: not reported

  • Diabetes: not reported

  • Current smoker: not reported

  • Exclusion criteria: bone disorder other than postmenopausal status; use of corticosteroids; prior treatment with other anti‐osteoporotic drugs

Interventions Treatment group
  • Abaloparatide: 80 μg/day self‐administered by SC injection


Control group 1
  • Placebo


Control group 2 (active comparator)
  • Teriparatide: 20 μg/day self‐administered by SC injection


Co‐interventions
  • Calcium: 500 to 1000 mg

  • Vitamin D: 400 to 800 IU

    • Actual use of calcium or vitamin D: not reported

Outcomes Primary outcome
  • New vertebral fractures


Secondary outcomes
  • Nonvertebral fractures

  • Moderate and severe vertebral fractures

  • Percentage change in the BMD of the lumbar spine, total hip, and femoral neck from baseline compared with teriparatide

  • Change in bone turnover biomarkers (s‐PINP, s‐CTX)

  • Adverse events

Notes
  • Funding source: The study was funded by Radius Health

  • Further information was requested, but no response was received

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Participants were randomly assigned to each treatment groups by means of a central, interactive, automated telephone system
Allocation concealment (selection bias) Low risk Allocation was concealed because participants were assigned to each group using a central, interactive, automated telephone system
Blinding of participants and personnel (performance bias)
All outcomes Low risk Active comparator (teriparatide) could not be repackaged and blinded. However, the comparison between abaloparatide and placebo, which was main purpose of this study, could be blinded
Blinding of outcome assessment (detection bias)
All outcomes Low risk Efficacy and safety outcomes were assessed by blinded and independent assessors
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Missing outcome data were balanced in numbers across intervention groups; however, the reasons for missing data were not stated
Selective reporting (reporting bias) High risk All predefined efficacy and safety outcomes were reported, however BMD was reported incompletely so that these data could not be entered in a meta‐analysis (no control group data)
Other bias High risk The study was funded by Radius Health