Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 47 of 165 for:    Recruiting, Not yet recruiting, Available Studies | Osteoporosis

Bisphosphonates for Prevention of Post-Denosumab Bone Loss

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03396315
Recruitment Status : Recruiting
First Posted : January 10, 2018
Last Update Posted : March 8, 2019
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
Elizabeth Shane, Columbia University

Brief Summary:

The primary goal of the study is to assess the extent to which bisphosphonate therapy will prevent decreases in bone mass that may occur after cessation of denosumab in premenopausal women with idiopathic osteoporosis (IOP) enrolled in AAAN0161 (FD05114) "Denosumab for the prevention of post-teriparatide bone loss in premenopausal women with idiopathic osteoporosis".

In addition, the investigator will observe participants for a second year off bisphosphonate therapy to assess duration of response.

The hypothesis is that bisphosphonate therapy with alendronate or zoledronic acid, initiated after recovery of bone remodeling activity, will prevent significant bone loss after discontinuing denosumab.


Condition or disease Intervention/treatment Phase
IOP Osteoporosis Drug: Alendronate Drug: Zoledronic Acid Phase 2

Detailed Description:

Osteoporosis in premenopausal women with normal menstrual function and no specific cause is termed idiopathic osteoporosis (IOP). IOP is a rare disease with an estimated prevalence of <200,000 affected premenopausal women in the United States.

Women with IOP completing at least one year and up to three years of denosumab (Protocol AAAN0161) will be offered participation in this open-label study in which they would choose whether to take oral alendronate 70 mg weekly for 12 months or a single intravenous dose of zoledronic acid 5 mg. Subjects and study personnel will be blinded to BMD outcomes until 12 months.

Discontinuation of denosumab is followed by substantial increases in bone turnover markers to well above baseline, bone resorption reaching twice baseline levels for about 6 months. Over the first 12 months off therapy, all the bone density gained on treatment is lost. Studies done at the institution has demonstrated the occurrence of multiple vertebral fractures in some patients who have stopped denosumab. Based upon these new fracture data, the Prolia label is currently recommending that consideration should be given to transition to another antiresorptive drug in patients stopping denosumab. The main goals of this extension study are to determine rates of bone loss and incidence of radiographic vertebral fractures during one year of bisphosphonate therapy (oral alendronate or intravenous zoledronic acid) initiated after completing denosumab.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: open-label study in which they would choose whether to take oral alendronate 70 mg weekly for 12 months or a single intravenous dose of zoledronic acid 5 mg.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bisphosphonates for Prevention of Post-Denosumab Bone Loss in Premenopausal Women With Idiopathic Osteoporosis
Actual Study Start Date : January 29, 2018
Estimated Primary Completion Date : January 1, 2023
Estimated Study Completion Date : January 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis

Arm Intervention/treatment
Active Comparator: alendronate
Subjects will receive oral alendronate
Drug: Alendronate
oral alendronate 70 mg weekly for 12 months will be given for the prevention of osteoporosis
Other Name: fosamax

Active Comparator: zoledronic acid
Subjects will receive zoledronic acid
Drug: Zoledronic Acid
single intravenous dose of zoledronic acid 5 mg will be given for the prevention of osteoporosis
Other Name: Reclast




Primary Outcome Measures :
  1. Difference in BMD at the Lumbar spine (L1-4) within group [ Time Frame: Baseline, 12 month ]
    Within-group difference (percent change) in BMD at the lumbar spine (L1-4) will be measured by Dual-energy X-ray absorptiometry (DXA) and calculated.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All women completing at least 12 months of Forteo treatment and at least 12 months of denosumab under previous research studies who remain without a diagnosis of an excluded medical condition and medication exposures as detailed below, will be offered enrollment into this study.

Exclusion Criteria:

  • Known intolerance to calcium supplements
  • Contraindications to bisphosphonate treatment:

    1. Hypocalcemia
    2. Pregnancy
    3. Known hypersensitivity to bisphosphonates
  • History of osteomalacia
  • History of osteonecrosis of the jaw
  • History of dental extraction or other invasive dental surgery within the prior 4 weeks
  • Invasive dental work planned in the next 12 months
  • Any condition or illness (acute, chronic, or history), which in the opinion of the Investigator might interfere with the evaluation of efficacy and safety during the study or may otherwise compromise the safety of the subject
  • Self-reported or known alcohol or drug abuse within the previous 12 months
  • Current or recent (within 1 year of enrollment) inflammatory bowel disease or malabsorption
  • Abnormal laboratory tests performed during Visit 1

    1. Renal insufficiency or liver disease: estimated glomerular filtration rate (eGFR) < 35 ml/min, aspartate aminotransferase (AST)/alanine aminotransferase (ALT) >50% above upper limit of normal
    2. Hypercalcemia, hypocalcemia
    3. Vitamin D deficiency: 25-Hydroxyvitamin D (25-OHD) < 30 ng/mL
  • Subjects must be willing to participate voluntarily. Specifically excluded are the following: 1) women less than 20 (or 35 in the case of those who wish to participate because they have low BMD); 2) protected individuals (institutionalized); 3) prisoners; 4) any other prospective participant who, for any reason, might not be able to give voluntary informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03396315


Contacts
Layout table for location contacts
Contact: Mariana Bucovsky, BA 212-305-7225 mb3523@cumc.columbia.edu

Locations
Layout table for location information
United States, Nebraska
Creighton University Not yet recruiting
Omaha, Nebraska, United States, 68131
Contact    402-280-4470      
Principal Investigator: Robert Recker, MD         
Sub-Investigator: Joan Lappe, MD         
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Mariana Bucovsky, BA    212-305-7225      
Principal Investigator: Elizabeth Shane, MD         
Sub-Investigator: Adi Cohen, MD         
Sponsors and Collaborators
Columbia University
Amgen
Investigators
Layout table for investigator information
Principal Investigator: Elizabeth Shane, MD Columbia University

Additional Information:
Publications:
Nishiyama K, Wang J, Young P, et al. Teriparatide Is Associated with Improved Microarchitecture and Estimated Bone Strength in Premenopausal Women with Idiopathic Osteoporosis: An HR-pQCT Study. American Society for Bone and Mineral Research Annual Meeting; 2013; Baltimore, MD: American Society for Bone and Mineral Research

Layout table for additonal information
Responsible Party: Elizabeth Shane, Professor of Medicine, Columbia University
ClinicalTrials.gov Identifier: NCT03396315     History of Changes
Other Study ID Numbers: AAAR5220
First Posted: January 10, 2018    Key Record Dates
Last Update Posted: March 8, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Elizabeth Shane, Columbia University:
premenopausal women

Additional relevant MeSH terms:
Layout table for MeSH terms
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Zoledronic Acid
Denosumab
Alendronate
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs