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Trial · Interventional

CompletedNot applicableResults postedRegistry data

Intervenous (IV) Zoledronic Acid After Forteo in Postmenopausal Women

This trial does not test a peptide that PepBank tracks.

  • Measures Teriparatide (PTH 1-34), does not give it. It appears in the eligibility rules.

Overview

Status
Completed
Phase
Not applicable
Enrollment
35 participants (actual)
Sponsor
The Cleveland Clinic · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
Aug 2006
Primary completion
Apr 2008
Completion
Apr 2008
First posted
8 Aug 2006 (estimated)
Last update posted
21 Apr 2017
Conditions
Osteoporosis

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2006200720082009
  1. N/A

    Intervenous (IV) Zoledronic Acid After Forteo in Postmenopausal Women

    NCT00361595

    Aug 2006 to Apr 2008

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The purpose of this study is to evaluate the adequacy of zoledronic acid in maintaining bone mass after two years of treatment with Forteo, in postmenopausal women.

Interventions

  • zoledronic acidDrug

Arms1

  • Experimental

    open label

    5 mg zoledronic acid in a single 15 minute IV

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in Lumbar Spine BMD (Bone Mineral Density) in g/cm^2 From Baseline to Month 12 Relative to Baseline as Measured by DXA (Dual-energy X-ray Absorptiometry)

    Time frame · Baseline and 12 months

Secondary outcomes(3)
  1. Change in Bone Density (Grams/cm^2) at the Total Hip at 6 and 12 Months

    Time frame · 6 months and 12 months

    Registry description

    Change in bone density (grams/cm\^2) at the total hip at 6 and 12 months. 12 month reported based on usual interval for bone density follow-up in clinical practice.

  2. Change in Serum C-telopeptide Type 1 Collagen (CTX) (at Day 10 and Months 2, 6, 9 and 12)

    Time frame · 12 months

    Registry description

    Change in serum c-telopeptide type 1 collagen (CTX) (at day 10 and months 2, 6, 9 and 12. 12 month values reported based on 12 month duraton of zolendronic acid effect.

  3. Change in Serum N-propeptide Type 1 Collagen (P1NP) (at Day 10 and Months 2, 6, 9 and 12)

    Time frame · 12 months

    Registry description

    Change in serum n-propeptide type 1 collagen (P1NP) (at day 10 and months 2, 6, 9 and 12. 12 month values reported based on 12 month duraton of zolendronic acid effect.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Baseline and 12 months

Change in Lumbar Spine BMD (Bone Mineral Density) in g/cm^2 From Baseline to Month 12 Relative to Baseline as Measured by DXA (Dual-energy X-ray Absorptiometry)

GroupValue (grams/cm^2)Spread
Open Label2.2.036
Secondary and other outcome results(3)
Secondary outcomeMean· 6 months and 12 months

Change in Bone Density (Grams/cm^2) at the Total Hip at 6 and 12 Months

GroupValue (grams/cm^2)Spread
Open Label2.4.031
Secondary outcomeMean· 12 months

Change in Serum C-telopeptide Type 1 Collagen (CTX) (at Day 10 and Months 2, 6, 9 and 12)

GroupValue (ng/ml)Spread
Open Label-49.137.6
Secondary outcomeMean· 12 months

Change in Serum N-propeptide Type 1 Collagen (P1NP) (at Day 10 and Months 2, 6, 9 and 12)

GroupValue (mcg/ml)Spread
Open Label-66.229.1

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Open Label5 mg zoledronic acid in a single 15 minute IV (intervenous)–0 / 358 / 35

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Female
Age
up to 85 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Postmenopausal women to age 85, inclusive * Finish treatment of 12 months or longer with Forteo * Signed informed consent prior to initiation of any study-mandated procedure. Exclusion Criteria: * Hip and spine DXA T-score \>-1.0 * Patients with 25-(OH) vitamin D levels less than 15 ng/mL at Visit 1. (Patient can be repleted with vitamin D 50,000 units biweekly for up to 2 months and re-screened anytime during the 2 months while continuing Forteo.) * Baseline renal insufficiency (calculated creatinine clearance less than 40.0 mL/min (MDRD) at Visit 1 and/or Visit 2 or urine dipstick greater than or equal to 2+ protein without evidence of contamination or bacteriuria (may be repeated one time at least a week apart if there is suspicion of contamination). Patients with calculated creatinine clearance equal to or greater than 40.0 mL/min and less than 60.0 mL/min or serum creatinine greater than the upper limit of normal at Visit 1 must be retested between Visit 1 and 2. Patients with calculated creatinine clearance greater than 60.0 mL/min and serum creatinine within normal limits at Visit 1 do not require re-test. * Patients who require re-test of creatinine clearance between Visit 1 and 2 will be excluded if there is an increase in serum creatinine greater than 0.5 mg/dL between Visit 1 and Visit 2. * Serum calcium \<8.5 or \>11.0 mg/dl at Visit 1 * AST or ALT greater than twice the upper limit of normal * Serum alkaline phosphatase greater than 1.5 times the upper limit of normal (liver fraction) * No history of retinopathy or nephropathy especially in the presence of uncontrollable IDDM with Hb1 AC \> 10% * Hypersensitivity to bisphosphonates * Treatment with biphosphonates while on Forteo * Prior treatment with i.v. biphosphonates * Estrogen, calcitonin, raloxifene use prior to Forteo treatment are not exclusions, but concomitant therapy during with any bone agents during the trial will not be permitted * Any prior use of strontium ranelate or sodium fluoride * Chronic use of systemic corticosteroids (oral or i.v.) within the last year: NOTE: Use of corticosteroids in forms such as topical creams, nasal or inhaled formulations or those injected locally (intra-articularly) are NOT exclusionary. * Prior exposure to anabolic steroids or growth hormone within 6 months prior to randomization * Treatment with any investigational drug(s) and/or devices within 30 days prior to randomization. * History of iritis or uveitis, except when secondary to trauma, and must have resolved for more than 2 years prior to randomization. * Cancer exclusions: * Patients with a new diagnosis or active treatment for any malignancy less than or equal to 12 months prior to Visit 1. * Patients with evidence of any metastases on or prior to randomization, or with a history of metastases * Subjects with evidence of paraneoplastic syndrome, especially those characterized by hypercalcemia during screening or by history * Patients with the following may be included: basal cell or squamous cell carcinoma of the skin, colonic polyps with non-invasive malignancy which have been removed, and Carcinoma in-situ (CIS) of the prostate (Stage I only) that has been surgically removed. * Previous major solid organ or bone marrow transplant recipient or on a transplant waiting list * Any disease of the spine that would preclude the proper acquisition of a lumbar spine DXA (L1-L4) e.g., implantable devices, scoliosis, ankylosing spondylitis, DJD. (Less than two lumbar spine vertebral bodies evaluable) * Active primary hyperparathyroidism or hypoparathyroidism * Subject with complete thyroidectomy * Active hyperthyroidism * Hypothyroidism not treated with adequate replacement therapy * History of multiple myeloma or Paget's disease * Patients with severe dental problems or current dental infections, or with recent or impending dental surgery within three months of dosing * 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 per protocol

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