A Phase II Study Evaluating SB-751689 in Post-Menopausal Women With Osteoporosis.

What Was Tested

In this phase 2 trial, researchers set out to test Teriparatide.

It had four arms (groups): Placebo (no intervention), Alendronate (active comparator), Teriparatide (active comparator) and Ronacaleret (experimental).

The registry classes the interventions as drug.

Who Took Part

564 actual participants took part.

It was open to women only aged from 18 years up to 79 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Informed consent: Subject is willing and able to provide written informed consent. Menopausal status: Ambulatory female aged \< 80 years at screening and \>5 years postmenopausal. T-Score: A subject with either no or only one prevalent vertebral fracture is eligible for inclusion if she satisfies one of the following T-score requirements:. Suitable vertebra: Two or more vertebra in the range of L1 to L4 that are suitable for BMD measurement by DXA. Protocol compliance: Subject who, in the opinion of the investigator, is willing and able to comply with the requirements of the protocol.

The full record lists 45 inclusion and 9 exclusion criteria; among the exclusions: calcium channel blockers: current therapy with calcium channel blockers diltiazem and verapamil; oral azole antifungals: current therapy with any oral azole antifungal; immunosuppressants: current therapy with cyclosporine or oral tacrolimus.

How the Study Was Run

The set-up was randomized, parallel-group and triple-blind.

Because people in this Teriparatide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received Teriparatide.

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2007-05-14 with completion listed for 2008-12-26.

It ran at 49 sites in United States (9), Germany (7), Spain (6), Australia (4), Argentina (3) and Belgium (3).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Percent Change From Baseline in Bone Marrow Density (BMD) at Month 12 Measured by Dual-Energy X-Ray Absorptiometry (DXA) Scans of the Lumbar Spine (L1-L4) (time frame: Baseline (Day 0) and 12 Months). Number of Participants With Hypercalcemia (time frame: Up to Month 12). Number of Participants Withdrew Due to Hypercalcemia (time frame: Up to Month 12).

It also tracked 14 secondary outcomes, for example Percent Change From Baseline to Month 6 in BMD Measured by DXA Scans of the Lumbar Spine (L1-L4), Percent Change From Baseline to Months 6 and 12 in BMD Measured by DXA Scans of the Hip (Total Hip, Femoral Neck and Trochanter), Percent Change From Baseline to Month 12 in the Total Vertebra Integral VOI at the Lumbar Spine as Measured by QCT Scans, Percent Change From Baseline to Month 12 in Cortical Thickness at the Hip as Measured by QCT Scans, Biochemical Markers of Bone Turnover: Levels of C-terminal Telopeptide α1 Chain of Type 1 Collagen (CTX1) and Biochemical Markers of Bone Turnover: Procollagen Type 1 N-terminal Propeptide (P1NP).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Teriparatide in 564 people.

With 564 participants it is a large trial for this field.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

More context: the Teriparatide compound page, all human trials.