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. 2023 Jun 21;2023(6):CD014788. doi: 10.1002/14651858.CD014788.pub2

Roux 1995.

Study characteristics
Methods Trial design: single‐site, double‐masked, randomised, placebo‐controlled, dose‐ranging trial
Participants Participants: 42 women were randomised; 40 women were analysed.
Mean age: 34.0 ± 6.5 years (range 20‐44 years)
Inclusion criteria:
  • Endometriosis diagnosed by signs or symptoms or laparoscopy


Exclusion criteria: 
  • Amenorrhoea

  • Taking drugs known to affect bone metabolism

  • Evidence of an associated disease

  • Interruption of more than 15 days in the administration of the drug


Setting: France
Timing: not stated
Interventions All participants received triptorelin 3.75 mg IM every four weeks + norgestrel acetate 5 mg/day during the first 3 weeks following injection and then 1 g calcium carbonate daily for 27 weeks. 
In addition:
Group 0: placebo intranasal spray,
Group 1: salmon calcitonin 100 IU IN daily, 
Group 2: salmon calcitonin 200 IU IN daily.
Outcomes
  • Bone Mineral Density

  • Adverse effects

  • Biochemical changes

Notes Intention‐to‐treat analysis: yes
Sample size calculation: yes
Funding: not stated
Author could not be contacted due to lack of information.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk "Randomly devided". No further details of method used to generate the randomisation sequence were provided.
Allocation concealment (selection bias) Unclear risk No details of method used to conceal allocation were provided.
Blinding of participants and personnel (performance bias)
All outcomes Low risk Double‐blind, placebo‐controlled study
Blinding of outcome assessment (detection bias)
All outcomes Low risk Double‐blind, placebo‐controlled study
Incomplete outcome data (attrition bias)
All outcomes Low risk 2 participants failed to complete the study ‐ one was lost to follow‐up and one was excluded due to orthopaedic material in the lumbar spine.
Selective reporting (reporting bias) Low risk The study protocol was not available but it was clear that the published reports included all expected outcomes, including those that were prespecified.
Other bias Low risk No other risk of bias detected