Effects of strontium ranelate on bone quality before dental implantation.

A double-blind, multicenter, international randomised study to assess the effects of 4 month-oral administration of 2g per day of strontium ranelate versus placebo on the bone quality and remodelling, as assessed on an alveolar bone biopsy extracted before dental implantation, in osteoporotic patients or in patients at risk of osteoporotic fracture.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-002370-23-IT

Enrollment

Registered

2011-12-28

Start date

2011-11-30

Completion date

Unknown

Last updated

2013-06-17

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

Conditions

Dental implantation in osteoporotic patients or in patients at risk of osteoporotic fracture. MedDRA version: 14.1 Level: SOC Classification code 10042613 Term: Surgical and medical procedures System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 14.1 Level: PT Classification code 10064143 Term: Dental implantation System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Trade Name: PROTELOS Pharmaceutical Form: Granules for oral suspension INN or Proposed INN: STRONTIUM RANELATE CAS Number: 135459-87-9 Current Sponsor code: S12911 Concentration unit: g gram(s) Concen

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Men or post-menopausal women, > or = 50 years, Osteoporotic patient or with a risk of osteoporotic fracture, Eligible for a premolar extraction followed by a dental implant placement, Without inter-radicular septum at extraction. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

Exclusion criteria: -Pathological findings in the jaw bone, -History of maxillar or cervico-facial irradiation, -Chronic inflammatory rheumatoid disease, -Inflammatory or metabolic bone disease,excluding osteoporosis, -Hypersensitivity to the active substances or to any of the excipients or to tetracycline.

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the effect of 4 month treatment with strontium ranelate in comparison with placebo on alveolar bone quality and alveolar bone turnover on alveolar biopsies;Secondary Objective: To assess the effect of 4 month treatment with strontium ranelate on: -alveolar bone microarchitecture, - alveolar bone texture. To assess biological and clinical safety over 6 months. Implant stability will be assessed after 6 months of treatment;Primary end point(s): - Evaluation of the efficacy by assessing alveolar bone quality and alveolar bone turnover;Timepoint(s) of evaluation of this end point: -Alveolar bone quality will be assessed by nanoindentation at M004 - Alveolar bone turnover will be assessed by histomorphometry at M004	—

Measure

Time frame

Main Objective: To assess the effect of 4 month treatment with strontium ranelate in comparison with placebo on alveolar bone quality and alveolar bone turnover on alveolar biopsies;Secondary Objective: To assess the effect of 4 month treatment with strontium ranelate on: -alveolar bone microarchitecture, - alveolar bone texture. To assess biological and clinical safety over 6 months. Implant stability will be assessed after 6 months of treatment;Primary end point(s): - Evaluation of the efficacy by assessing alveolar bone quality and alveolar bone turnover;Timepoint(s) of evaluation of this end point: -Alveolar bone quality will be assessed by nanoindentation at M004 - Alveolar bone turnover will be assessed by histomorphometry at M004

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Secondary

Measure	Time frame
Secondary end point(s): - Other parameters will be assessed by histomorphometry: resorption, microarchitecture, bone microarchitecture, texture analysis and implant stability - Safety will be assessed by: collection of adverse events, biological parameters evaluation, clinical examination;Timepoint(s) of evaluation of this end point: - Resorption, microarchitecture and bone microarchitecture will be assessed at M004 - Texture analysis will be assessed at M000 and M004 - Implant stability will be assessed at M006 - Safety measurements over 6 months.	—

Measure

Time frame

Secondary end point(s): - Other parameters will be assessed by histomorphometry: resorption, microarchitecture, bone microarchitecture, texture analysis and implant stability - Safety will be assessed by: collection of adverse events, biological parameters evaluation, clinical examination;Timepoint(s) of evaluation of this end point: - Resorption, microarchitecture and bone microarchitecture will be assessed at M004 - Texture analysis will be assessed at M000 and M004 - Implant stability will be assessed at M006 - Safety measurements over 6 months.

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Countries

Brazil, Germany, Italy

Contacts

Public ContactPROJECT MANAGER - ALESSANDRA MINASI

ISTITUTO DI RICERCA SERVIER srl

infoirs@netgrs.it06 669081

Outcome results

None listed

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