An international study to assess the effects of strontium ranelate in the reduction of bone loss around the metal implant, in patients with hip prosthesis

A prospective, controlled, double blind, international study to assess the effects of strontium ranelate vs placebo on the reduction of periprosthetic bone loss in patients with total hip arthroplasty

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN15928978

Enrollment

126

Registered

2011-08-04

Start date

2011-05-01

Completion date

Unknown

Last updated

2020-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periprosthetic bone loss / total hip arthroplasty Musculoskeletal Diseases Periprosthetic bone loss

Interventions

Intervention (63 paticipants) - One sachet of 2g of strontium ranelate daily Placebo (63 paticipants) Total duration of intervention is 12 months.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Caucasian male or postmenopausal women 2. Age less than or equal to 50 years 3. Patients with conventional primary total hip arthroplasty, cementless femoral stem and primary coxarthrosis as indication for total hip arthroplasty

Exclusion criteria

Exclusion criteria: 1. Short femoral stem 2. Any perioperative complication 3. Patient with inflammatory arthropathy 4. Impossibility to perform Dual-emission X-ray absorptiometry (DXA) 5. Increase risk or history of venous thromboembolism (VTE) 6. Known hypersensitivity or contraindication to the study drug or Calperos D3® 7. Concomittant treatments likely to interfere with bone metabolism

Design outcomes

Primary

Measure	Time frame
The relative change of periprosthetic bone mineral density (BMD) in region 7 of Gruen after total hip arthroplasty over 12 months	—

Secondary

Measure	Time frame
1. The relative change of other regions of Gruen over 12 months 2. Safety over 12 months	—

Countries

Belgium, Brazil, Germany, Italy, Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026