Multi-Center Phase II Study to Compare MER-101 20mg Tablets to Intravenous Zometa 4mg in Male Bisphosphonate-Naive, Hormone Refractory Prostate Cancer Patients

A Multi-Center Phase II Study to Compare MER-101 (20mg) Tablets To Intravenous Zometa 4mg in Male Bisphosphonate-Naive Hormone Refractory Prostate Cancer Patients

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00636740

Enrollment

Registered

2008-03-14

Start date

2008-02-29

Completion date

2009-02-28

Last updated

2009-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hormone-Refractory Prostate Cancer

Keywords

Prostate cancer, hormone resistant, bisphosphonate

Brief summary

The objective of MER-101-03 is to examine the effects of two different dosing regimens of MER-101 20mg tablets versus Zometa 4mg IV infusion once-monthly therapy. The effects will be monitored on a weekly basis by measuring various markers of bone metabolism. Patients to be enrolled will be those who have not received any previous bisphosphonate therapy. The study will be carried out on prostate cancer patients who are no longer on hormone therapy. Treatment in the study will be for a 2-month period.

Interventions

DRUGZoledronic Acid 20mg Tablets

Oral enteric coated tablets, 20mg, weekly, 8 weeks

DRUGZoledronic Acid

Zoledronic Acid infusion, 4mg, every 4 weeks for 8 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Prostate Cancer with rising PSA levels after hormone treatment and bone metastasis based on an X-ray.

Exclusion criteria

* Already be on a bisphosphonate treatment (Zometa, Fosamax, Actonel)

Design outcomes

Primary

Measure	Time frame
Effects on 4 markers of bone metabolism	Weekly

Secondary

Measure	Time frame
Brief Pain Inventory	Monthly

Countries

Estonia, Latvia, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026