Efficacy Study of Zoledronic Acid and Teriparatide Combination Therapy in Women With Osteoporosis

What Was Tested

This registered phase 3 trial tested Teriparatide.

The purpose of this study is to assess the effects of zoledronic acid administered at the same time with teriparatide compared to zoledronic acid alone and teriparatide alone on bone mineral density (BMD) gain in the lumbar spine and total hip.

It had three arms (groups): Zoledronic acid plus teriparatide (active comparator), Zoledronic acid (experimental) and Placebo zoledronic acid plus teriparatide (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 412 actual participants took part.

It was open to women only aged from 45 years up to 89 years.

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

Examples of who could join: Postmenopausal (PMO) women between 45 and 89 years of age. Bone mineral density T score of -2.5 or less at femoral neck, total hip or lumbar spine OR.

The full record lists 3 inclusion and 9 exclusion criteria; among the exclusions: any prior use of strontium; any past or active kidney disease or problems with kidney function; calcium levels in blood within the normal range.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

The participants were allocated by chance, so the Teriparatide group and the comparison group should start out alike.

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, care provider, investigator and outcomes assessor.

It started in 2006-12 with completion listed for 2009-02.

It ran at 33 sites in United States (18), Germany (6), Belgium (5) and Spain (4).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Week 52 (time frame: Baseline through Week 52).

It also tracked 4 secondary outcomes, for example Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Week 13 and Week 26, Percent Change From Baseline in Total Hip Bone Mineral Density (BMD) at Week 13, Week 26 and Week 52, Bone Resorption and Formation Biochemical Markers : N-terminal Propeptide of Type I Collagen (P1NP) and Bone Resorption and Formation Biochemical Markers : Beta C-terminal Telopeptides of Type I Collagen (β-CTx).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Teriparatide in 412 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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