NCT02313727

Brief Summary

It will be a pilot, 2 year, prospective, randomized, double-blind, placebo-controlled (for pamidronate) study. All patients with AS will receive treatment with TNF inhibitor, while randomization will be performed for pamidronate versus placebo group. Primary outcome will be the rate of radiographic progression of AS, calculated after 24 months of combined treatment.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Dec 2014

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 1, 2014

Completed
Same day until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 10, 2014

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

December 10, 2014

Status Verified

November 1, 2014

Enrollment Period

2.5 years

First QC Date

December 1, 2014

Last Update Submit

December 8, 2014

Conditions

Ankylosing Spondylitis

Outcome Measures

Primary Outcomes (2)

  • modified stock ankylosing spondylitis spine (mSASS) score

    calculated by X-ray films of the spine

    24 months

  • Bath ankylosing spondylitis radiographic index (BASRI)

    calculated by X-ray films of the spine

    24 months

Secondary Outcomes (4)

  • Bath ankylosing spondylitis disease activity index (BASDAI)

    monthly from the date of randomization up to 24 months

  • Ankylosing spondylitis disease activity index (ASDAS)

    monthly from the date of randomization up to 24 months

  • Bath ankylosing spondylitis functional index (BASFI)

    monthly from the date of randomization up to 24 months

  • Bath ankylosing spondylitis metrology index (BASMI)

    monthly from the date of randomization up to 24 months

Study Arms (2)

pamidronate

ACTIVE COMPARATOR

pamidronate

Drug: Pamidronate

placebo

PLACEBO COMPARATOR

placebo

Other: Placebo (NaCl 0.9%)

Interventions

PamidronateDRUG

intravenous infusion of pamidronate 60 mg

pamidronate
Placebo (NaCl 0.9%)OTHER

intravenous infusion of NaCl 0.9% 500 ml

placebo

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • presence of spinal syndesmophytes
  • normal renal and liver function
  • eligibility to receive anti-TNF treatment according to local guidelines

You may not qualify if:

  • unwilling to sigh the informed consent
  • presence of significant systemic or organ-limited disorders, other than AS
  • any contraindication for anti-TNF or pamidronate treatment
  • presence of acute dental/periodontal disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bnai Zion Medical Center

Haifa, 38041, Israel

Location

Related Publications (3)

  • Slobodin G, Rosner I, Feld J, Rimar D, Rozenbaum M, Boulman N, Odeh M. Pamidronate treatment in rheumatology practice: a comprehensive review. Clin Rheumatol. 2009 Dec;28(12):1359-64. doi: 10.1007/s10067-009-1256-2. Epub 2009 Aug 19.

    PMID: 19690938BACKGROUND

  • Slobodin G, Rosner I, Rimar D, Boulman N, Rozenbaum M, Odeh M. The synergistic efficacy of adalimumab and pamidronate in a patient with ankylosing spondylitis. Clin Rheumatol. 2010 Jul;29(7):793-4. doi: 10.1007/s10067-010-1378-6. Epub 2010 Jan 29.

    PMID: 20111975BACKGROUND

  • Pederson L, Ruan M, Westendorf JJ, Khosla S, Oursler MJ. Regulation of bone formation by osteoclasts involves Wnt/BMP signaling and the chemokine sphingosine-1-phosphate. Proc Natl Acad Sci U S A. 2008 Dec 30;105(52):20764-9. doi: 10.1073/pnas.0805133106. Epub 2008 Dec 15.

    PMID: 19075223BACKGROUND

MeSH Terms

Conditions

Spondylitis, Ankylosing

Interventions

PamidronateSodium Chloride

Condition Hierarchy (Ancestors)

Axial SpondyloarthritisSpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesAnkylosisJoint DiseasesArthritis

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2014

First Posted

December 10, 2014

Study Start

December 1, 2014

Primary Completion

June 1, 2017

Study Completion

September 1, 2017

Last Updated

December 10, 2014

Record last verified: 2014-11

Locations

IL(1)