Postmenopausal Osteoporosis

Overview

FDA and EMEA regulatory guidelines state that the preclinical efficacy of any new therapy for postmenopausal osteoporosis should be tested with the rat ovariectomy (OVX) model in order to secure regulatory approval.

The ratOVX model offered by Pharmatest is the most commonly used and extensively studied animal prototype of postmenopausal osteoporosis.

Capabilities

Pharmatest can test clients’ new drug candidates in the rat OVX model in conformance with FDA and EMEA regulatory guidelines. When necessary a preliminary two-week study can be first performed to identify the best out of several potential compounds and find their optimal doses.

Efficacy of the best compounds can then be confirmed with a more extensive eight-week study before entering a 12-month regulatory study. Preclinical efficacy studies can also be performed with intact female rats, or intact female mice that require lower amount of test compound.

Pharmatest has specific standard study setups for testing compounds with anti-catabolic and anabolic bone effects. The preclinical research testing center also provides tailored study setups for testing biosimilars and functional foods that have less extensive regulatory requirements.

Bone Analysis Services

Pharmatest also offers a range of bone analysis services. The standard study setups in different disease models include different combinations of bone analysis methods that can also be used as stand-alone services, where clients send samples for Pharmatest to perform the selected measurements and provide the results. These bone analysis methods include:

• • Micro-computed tomography (µCT)
  • Peripheral quantitative computed tomography (pQCT)
  • Radiographic imaging and image analysis
  • Full-service bone histomorphometry, including static and dynamic parameters
  • Processing of tissue samples for histological analysis, including tissue preparation and embedding to paraffin or plastic, and a variety of histological staining techniques
  • Bone ash weight analysis
  • Bone biomechanical testing, including cantilever bending, three-point bending and compression tests
  • Biochemical markers of bone turnover in serum, including procollagen I N-terminal propeptide (PINP), N-terminal mid-fragment of osteocalcin (OC), C-terminal cross-linked telopeptides of type I collagen (CTX-I) and tartrate-resistant acid phosphatase 5b (TRACP 5b)
  • Gene expression analysis using microarrays (e. g. Affymetrix, Agilent, Illumina) and bioinformatics services

Resources

Click on postmenopausal osteoporosis models for more information.
Click on Pharmatest to contact the company directly.

Supplier Information
Supplier: Pharmatest Services Ltd
Address: Itäinen Pitkäkatu 4 C, 5th floor, 20520 Turku, Finland
Tel: +358 2 278 4700
Fax: +358 2 278 4710
Website: www.pharmatest.com