Study on the ability of zoledronic acid to prevent worsening of radiographs of hands and feet of patients with rheumatoid arthritis diagnosed less than 2 years ago and who have few symptoms in their joints by making treatment with the drugs commonly used for the management of disease.

Randomized clinical trial on the prevention of radiographic progression with zoledronic acid in patients with early rheumatoid arthritis and low disease activity - Prevention of radiographic progression in rheumatoid arthritis with zoledronic acid

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-005001-31-ES

Enrollment

Unknown

Registered

2014-02-07

Start date

2014-03-25

Completion date

Unknown

Last updated

2016-09-19

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

Conditions

Rheumatoid arthritis MedDRA version: 16.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Interventions

Trade Name: Zoledronic acid Product Name: Zoledronic acid Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: ZOLEDRONIC ACID CAS Number: 118072-93-8 Concentration unit: mg

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age ? 18 years 2. Patients with RA of less than 2 years of evolution 3. DMARD therapy (methotrexate alone or methotrexate, leflunomide or methotrexate within COBRA strategy) on stable dose for at least 6 weeks prior to study entry 4. Patients not treated with glucocorticoids or under stable dose of prednisone up to 5 mg / day or equivalent dose of another glucocorticoid 5. Low disease activity (DAS28 =65 years) yes F.1.3.1 Number of subjects for this age range 32

Exclusion criteria

Exclusion criteria: 1. Previous or current treatment with biological drugs used for the treatment of RA (infliximab, adalimumab, etanercept, certolizumab, golimumab, rituximab, abatacept, tocilizumab) 2. Pretreatment with: a. Bisphosphonates in the 5 years prior to the onset of RA b. Calcitonin, raloxifene, bazedoxifene, strontium ranelate, teriparatide and denosumab in the year before the onset of RA 3. Contraindication to treatment with zoledronic acid: a. Hypersensitivity to bisphosphonates b. Hypocalcemia c. Glomerular filtration rate <35 mL / min d. Pregnant (negative pregnancy test) and lactating women e. Poor oral hygiene f. Pending invasive dental procedure 4. Serum levels of calcidiol lower than 25 nmol/L (10 ng/mL). 5. Simultaneous participation in another clinical trial

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the progression of radiographic damage in patients with early RA in current treatment with DMARDs and low disease activity to which treatment with zoledronic acid is added, compared to a no treatment control population.;Secondary Objective: a. To assess the progression of radiological damage after one year b. To compare the loss of periarticular bone mass by DXA bone densitometry of the hands at two years c. To compare general bone loss by DXA bone densitometry of lumbar spine and proximal femur at two years d. To determine the size variation of carpal and metacarpophalangeal joints erosions by high resolution computed tomography (CT), at two years e. To assess the predictive value of response to previous targets of serum OPG, RANKL, DKK-1 and sclerostin assets at the beginning. f. To determine the proportion of patients that eventually require the addition of biological treatment for presenting sustained disease activity. g. To determine the proportion of patients that eventually require the addition of biological treatment for presenting radiological progression. h. To study the safety of zoledronic acid.;Primary end point(s): The primary study endpoint is the progression of radiological damage assessed in a blinded way by the difference in the Sharp-van der Heijde index (SHI) in radiographs of hands and feet after two years.;Timepoint(s) of evaluation of this end point: Baseline and after two years	—

Measure

Time frame

Main Objective: To assess the progression of radiographic damage in patients with early RA in current treatment with DMARDs and low disease activity to which treatment with zoledronic acid is added, compared to a no treatment control population.;Secondary Objective: a. To assess the progression of radiological damage after one year b. To compare the loss of periarticular bone mass by DXA bone densitometry of the hands at two years c. To compare general bone loss by DXA bone densitometry of lumbar spine and proximal femur at two years d. To determine the size variation of carpal and metacarpophalangeal joints erosions by high resolution computed tomography (CT), at two years e. To assess the predictive value of response to previous targets of serum OPG, RANKL, DKK-1 and sclerostin assets at the beginning. f. To determine the proportion of patients that eventually require the addition of biological treatment for presenting sustained disease activity. g. To determine the proportion of patients that eventually require the addition of biological treatment for presenting radiological progression. h. To study the safety of zoledronic acid.;Primary end point(s): The primary study endpoint is the progression of radiological damage assessed in a blinded way by the difference in the Sharp-van der Heijde index (SHI) in radiographs of hands and feet after two years.;Timepoint(s) of evaluation of this end point: Baseline and after two years

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Secondary

Measure	Time frame
Secondary end point(s): In patients with early RA in current treatment with DMARDs and low disease activity to whom zoledronic acid or no treatment is added: a. To assess the progression of radiological damage after one year b. To compare the loss of periarticular bone mass by DXA bone densitometry of the hands at two years c. To compare general bone loss by DXA bone densitometry of lumbar spine and proximal femur at two years d. To determine the size variation of carpal and metacarpophalangeal joints erosions by high resolution computed tomography (CT), at two years e. To assess the predictive value of response to previous targets of serum OPG, RANKL, DKK-1 and sclerostin assets at the beginning of the study treatments. f. To determine the proportion of patients that eventually require the addition of biological treatment for presenting sustained disease activity. g. To determine the proportion of patients that eventually require the addition of biological treatment for presenting radiological progression. h. To study the safety of zoledronic acid.;Timepoint(s) of evaluation of this end point: Timepoints are specified for every secondary endpoint in section E.5.2.	—

Measure

Time frame

Secondary end point(s): In patients with early RA in current treatment with DMARDs and low disease activity to whom zoledronic acid or no treatment is added: a. To assess the progression of radiological damage after one year b. To compare the loss of periarticular bone mass by DXA bone densitometry of the hands at two years c. To compare general bone loss by DXA bone densitometry of lumbar spine and proximal femur at two years d. To determine the size variation of carpal and metacarpophalangeal joints erosions by high resolution computed tomography (CT), at two years e. To assess the predictive value of response to previous targets of serum OPG, RANKL, DKK-1 and sclerostin assets at the beginning of the study treatments. f. To determine the proportion of patients that eventually require the addition of biological treatment for presenting sustained disease activity. g. To determine the proportion of patients that eventually require the addition of biological treatment for presenting radiological progression. h. To study the safety of zoledronic acid.;Timepoint(s) of evaluation of this end point: Timepoints are specified for every secondary endpoint in section E.5.2.

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Countries

Spain

Contacts

Public ContactCarmen Gómez-Vaquero

Hospital Universitari de Bellvitge

carmen.gomez@bellvitgehospital.cat34932607712

Outcome results

None listed

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