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OsteoporosisPhase 4NCT00431444

Effects of Zoledronic Acid and Raloxifene on Bone Turnover Markers in Postmenopausal Women With Low Bone Mineral Density

A Phase 4 study testing Raloxifene and Zoledronic acid in people with Osteoporosis, run by Novartis at 17 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will compare the effects of Zoledronic acid and Raloxifene in reducing bone turnover markers in postmenopausal women with low bone mineral density over 6 months. Read more about this study

Who is it for?
Ages 45 to 80 years, women only
Conditions the study is for
Osteoporosis
What is being tested?
Raloxifene and Zoledronic acid
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
110 participants
Where
17 sitesUnited States
Study dates
Jan 2007to Jul 2008
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 80 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Females, between 45 and 80 years (inclusive) of age, considered post-menopausal according to one of the following guidelines:
  • Cessation of menses for 18 months in women < 50 years of age
  • Cessation of menses for 12 months in women age 50 years or over
  • Documented bilateral oophorectomy at least 1 year previously
  • Documented T score of less than or equal to -1.5 on dual energy X-ray absorptiometry (DXA) scan at the lumbar spine, total hip or femoral neck within 24 months prior to screening, and clinically indicated for treatment with bisphosphonates (BPs) for osteopenia or osteoporosis
  • Signed informed consent prior to initiation of any study procedure

Who cannot join

  • Prior treatment with i.v. bisphosphonates within the last 2 years
  • Previous use of oral bisphosphonates within the past 2 years (unless used for less than 8 weeks*).
  • *NOTE: If used less than 8 weeks, the washout period is 6 months.
  • Treatment with raloxifene, calcitonin, tibolone or hormone replacement therapy. The washout period for these medications is 6 months prior to randomization.
  • Any treatment with strontium renalate, sodium fluoride or parathyroid hormone
  • Use of systemic high dose corticosteroids at an average dose of ≥ 7.5 mg per day of oral prednisone or equivalent for a period of three months or more within the previous year
Show all 21Show fewer
  • Treatment with any investigational drug within 30 days prior to randomization
  • Any woman of child bearing potential
  • Patients with fractures occurring within three months prior to randomization
  • History of hypersensitivity to bisphosphonates
  • History of non-traumatic uveitis or iritis, within 2 years prior to study entry.
  • A history of invasive malignancy of any organ system, treated or untreated, within the past 12 months prior to screening; excluding, basal cell or squamous cell carcinoma of the skin, colonic polyps with non-invasive malignancy which have been removed, Ductal Carcinoma in-situ (DCIS) that has been surgically removed, and Carcinoma in-situ (CIS) of the uterine cervix that has been surgically removed.
  • Previous major solid organ transplant recipient or on a transplant waiting list
  • History of hyperparathyroidism, hypoparathyroidism, Osteogenesis imperfecta, Paget's disease or any metabolic bone disease other than osteoporosis
  • Any medical condition which would interfere with the action of the study drug or limit life expectancy to less than 6 months
  • Any medical or psychiatric condition which, in the opinion of the investigator, would preclude the participant from adhering to the protocol or completing the trial
  • Active dental infection, unhealed dental extraction or planned oral surgery within 3 month prior to randomization.
  • Calculated creatinine clearance < 30 mL/min
  • Greater than 2+ protein on urine dipstick without evidence of contamination or bacteriuria (may be repeated one time, at least a day apart).
  • Serum calcium > 2.75 mmol/L (11.0 mg/dL) or < 2.08 mmol/L (8.3 mg/dL) at screening
  • AST, ALT or serum alkaline phosphatase greater than twice the upper limit of normal

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

United States17 sites

  • Associated Pharma Research Center

    Buena Park, California, 90620

  • Kernodle Clinic, Inc.

    Burlington, North Carolina, 27215

  • Texas Institute for Clinical Research

    Fort Worth, Texas, 76104

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida, 32216

  • Women's Physicians of Jacksonville

    Jacksonville, Florida, 32256

  • UMDNJ-Robert Wood Johnson Medical Center

    New Brunswick, New Jersey, 08901

  • Columbia University

    New York, New York, 10032

  • Alegent Health

    Omaha, Nebraska, 68152

  • Specialty Medical and Research Center

    Pahrump, Nevada, 89048

  • Women's Health Research

    Phoenix, Arizona, 85015

  • The Portland Clinic

    Portland, Oregon, 97205

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • Valley Women's Health Clinic

    Renton, Washington, 98055

  • Springfield Clinic

    Springfield, Illinois, 62703

  • Consultants in Women's Health Care

    St Louis, Missouri, 63131

  • Tampa Clinical Research

    Tampa, Florida, 33624

  • Study site

    Washington D.C., District of Columbia, 20036

Other trials in United States

About this study

Official title: A Multi-center, Randomized, Double-blind, Double-dummy Study in Postmenopausal Women With Low Bone Mineral Density to Compare the Effects of a Single Dose of i.v. Zoledronic Acid 5 mg, With Daily Oral Raloxifene 60 mg OD on Bone Turnover Markers

This study will compare the effects of Zoledronic acid and Raloxifene in reducing bone turnover markers in postmenopausal women with low bone mineral density over 6 months.

Conditions
Osteoporosis
Being tested
Raloxifene, Zoledronic acid, Placebo oral pills, Placebo intravenous (i.v.) infusion
Keywords
Osteoporosis, Post-menopausal, Bone mineral density
Medical subject headings
Osteoporosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RaloxifeneDrug

  • Zoledronic acidDrug

    Also called Reclast, Aclasta

  • Placebo oral pillsDrug

  • Placebo intravenous (i.v.) infusionDrug

Study groups in NCT00431444
Study groupRoleWhat they receive
Zoledronic AcidActive comparatorZoledronic acid 5 mg (single i.v. infusion) + daily oral placebo for 6 months (zoledronic acid group)
Receives: Drug: Zoledronic acid; Drug: Placebo oral pills
RaloxifeneActive comparatorPlacebo (single i.v. infusion) + oral raloxifene 60 mg/day for 6 months (raloxifene group)
Receives: Drug: Raloxifene; Drug: Placebo intravenous (i.v.) infusion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in Urine N-telopeptide of Type 1 Collagen (NTx.)

    The primary efficacy variable was the change from baseline in urine NTx (corrected by creatinine). The primary analysis time point was at 6 months of treatment. The results are reported as nanomoles (nM) of bone collagen equivalents (BCE) per millimole (mM) of urine creatinine.

    Measured: Baseline and 6 months

Secondary outcomes (9)

  1. Change From Baseline in Urine NTx at 2 Months

    The results are reported as nanomoles (nM) of bone collagen equivalents (BCE) per millimole (mM) of urine creatinine.

    Measured: Baseline and 2 months

  2. Change From Baseline in Urine NTx at 4 Months

    The results are reported as nanomoles (nM) of bone collagen equivalents (BCE) per millimole (mM) of urine creatinine.

    Measured: Baseline and 4 months

  3. Change From Baseline in Serum Bone Specific Alkaline Phosphatase (BSAP) at 2 Months

    Measured: Baseline and 2 months

  4. Change From Baseline in Serum Bone Specific Alkaline Phosphatase (BSAP) at 4 Months

    Measured: Baseline and 4 months

  5. Change From Baseline in Serum Bone Specific Alkaline Phosphatase (BSAP) at 6 Months

    Measured: Baseline and 6 months

  6. Overall Principal Investigator Satisfaction Assessed by Satisfaction Questionnaire

    The investigator was asked to complete satisfaction questionnaires at baseline (Visit 2/Day 1) when each patient's i.v. drug administration occurred. The questionnaire assessed overall satisfaction with the i.v. infusion procedure. The possible answers to the question were: "not at all," "a little," "somewhat," "quite," or "completely."

    Measured: Immediately after infusion procedure

  7. Overall Nurse Satisfaction Assessed by Satisfaction Questionnaire

    The study coordinator (nurse) was asked to complete satisfaction questionnaires at baseline (Visit 2/Day 1) when each patient's i.v. drug administration occurred. The questionnaire assessed overall satisfaction with the i.v. infusion procedure. The possible answers to the question were: "not at all," "a little," "somewhat," "quite," or "completely."

    Measured: Immediately after infusion procedure

  8. Overall Patient Satisfaction Assessed by Satisfaction Questionnaire

    Patients were asked to complete the satisfaction questionnaire at baseline. The questionnaire assessed overall satisfaction with the i.v. infusion procedure. The possible answers to the question were: "not at all," "a little," "somewhat," "quite," or "completely."

    Measured: Immediately after infusion procedure

  9. Patient Preference at 6 Months for Annual i.v Therapy or Daily Oral Regimens

    At the end-of-study visit, Month 6, patients were asked to complete a questionnaire to assess preference for the different treatment modalities (annual i.v. infusion vs. daily oral capsule). The possible answers to question were: "once a year i.v. infusion," "once daily pill," or "both are equal."

    Measured: At 6 month visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2007 (estimated)
  2. Study startJan 2007
  3. Primary completionJul 2008
  4. Study completionJul 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00431444
Sponsor's protocol ID
CZOL446HUS121
Status last verified
Mar 2011
First submitted
1 Feb 2007
Last updated
29 Mar 2011

Publications

  • Bachmann G, Kriegman A, Goncalves J, Kianifard F, Warren M, Simon JA. Effect of zoledronic acid compared with raloxifene on bone turnover markers in postmenopausal women with low bone density. Menopause. 2011 Aug;18(8):851-6. doi: 10.1097/gme.0b013e31820b80f1.

    PubMed 21796066

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Raloxifene and Zoledronic acid in people with Osteoporosis, run by Novartis at 17 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Mar 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Urine N-telopeptide of Type 1 Collagen (NTx.) (time frame: Baseline and 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00431444, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2011; AzTrials last refreshed its copy on 8 Nov 2026.

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