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Abstract Number: 84

New Formulation With Potential To Prevent and Treat Osteoporosis and Osteoarthritis

A. Torrent1, E. Montell2, J. Vergés1, P. Dalmau3, R. Ruhí3, M.C. Carceller4, A. Blanco4, M.C. Terencio4, M.L. Ferrándiz4 and M.J. Alcaraz5, 1Pre-Clinical R&D Area, Pharmascience Division, BIOIBERICA S.A., Barcelona, Spain, 2Pharmascience Division, BIOIBERICA S.A., Barcelona, Spain, 3Technological Extraction Dept, BIOIBERICA S.A., Palafolls, Spain, 4Department of Pharmacology and IDM, University of Valencia, Burjassot, Spain, 5University of Valencia, Burjasot, Valencia, Spain

Meeting: 2013 ACR/ARHP Annual Meeting

Keywords: Animal models, cartilage, Osteoarthritis, osteoporosis and treatment

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Session Information

Title: Biology and Pathology of Bone and Joint (Cartilage and Osteoarthritis)

Session Type: Abstract Submissions (ACR)

Background/Purpose:

Osteoarthritis (OA) is a multidimensional disease that affects all anatomical joint structures, particularly cartilage, synovium and subchondral bone. In turn, osteoporosis (OP) is a skeletal disorder characterized by a compromised bone strength which substantially increases the risk of fracture. In the past, attention was focused on a supposed inverse relationship between OA and OP, since both disorders usually affect the elderly, but were regarded to rarely coexist in a single person. However, recent studies have revealed several factors which contribute to the pathogenesis of both disorders (Bultink et al, 2013). Despite this, there is not any drug at the moment approved for the simultaneous prevention and treatment of osteoporosis and osteoarthritis.

The aim of this study was to investigate the effect of a new formulation in a combined rat model of OP and OA. The formulation (BIS076) contains Vitamin D3, Hydroxyapatite as a source of calcium and a natural extract from porcine cartilage. The latter is rich in bioactive substances due to the mild conditions used in the manufacturing process.

Methods:

OP was induced by ovariectomy (OVX) in female Wistar rats and, two weeks after, OA was induced by Anterior Cruciate Ligament Transection (ACLT). Sixty female rats were assigned into the following groups: Sham Group, OVX + ACLT Group (Vehicle) and BIS076 Groups. BIS076 was administered daily during 12 weeks at two doses, 163.5 mg/kg/day and 245 mg/kg/day which correspond approximately to 1400 mg/day and 2100 mg/day in humans. For the assessment of OA, histology was performed and cartilage degeneration was evaluated by means of the OARSI score (Pritzker et al, 2006). Synovitis degree was estimated according to the score proposed by Krenn et al (2006). Bone microarchitecture and density were assessed by Micro-Computed Tomography (microCT).

Results:

The preparation BIS076 has been shown to induce, at the 2 doses tested, a significant reduction (approximately 50%) of the cartilage degradation according to the OARSI score. Synovial inflammation was strongly reduced as well. In addition, microCT revealed that BIS076 treatment exerted a positive effect in bone structure, especially at the high dose: Significant increase in bone volume (p<0.05), bone surface density (p<0.01), trabecular number (p<0.01) and significant reduction in the trabecular bone pattern factor (p<0.01) compared to the Vehicle Group.

Conclusion:

Our data demonstrate that treatment with BIS076 could be an effective strategy to control the progression of experimental Osteoarthritis and Osteoporosis. This approach holds promise for the development of improved therapies targeting these chronic and disabling diseases.


Disclosure:

A. Torrent,

BIOIBERICA,

3;

E. Montell,

BIOIBERICA S.A.,

3;

J. Vergés,

BIOIBERICA S.A.,

3;

P. Dalmau,

BIOIBERICA S.A.,

3;

R. Ruhí,

BIOIBERICA S.A.,

3;

M. C. Carceller,
None;

A. Blanco,
None;

M. C. Terencio,
None;

M. L. Ferrándiz,
None;

M. J. Alcaraz,
None.

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