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Study Of The Efficacy And Security Of Ibandronate For Osteoporosis Treatment In A HIV-Infected Patients Cohort

This study has suspended participant recruitment.
(Financial difficulties)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00662077
First Posted: April 21, 2008
Last Update Posted: August 1, 2008
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. Read our disclaimer for details.
Information provided by:
Germans Trias i Pujol Hospital
  Purpose
This project wills to determine the incidence of osteoporosis in our population of HIV-infected patients and to assess the efficacy and security of ibandronate, whose efficacy in post-menopausal women has already been proved.

Condition Intervention Phase
HIV Infections Drug: Ibandronate Behavioral: Lifestyle modifications Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study Of The Efficacy And Security Of Ibandronate For Osteoporosis Treatment In A HIV-Infected Patients Cohort

Resource links provided by NLM:


Further study details as provided by Germans Trias i Pujol Hospital:

Primary Outcome Measures:
  • Increase in lumbar (L2-4) and femoral (trochanter, femur neck, total femur and hip) t-score bone mineral density [ Time Frame: BL, W24, W48, W72, W96 ]

Secondary Outcome Measures:
  • Adverse events [ Time Frame: BL, W12, W24, W36, W48, W60, W72, W80, W96 ]
  • Lab tests [ Time Frame: BL, W12, W24, W36, W48, W60, W72, W80, W96 ]
  • Related clinical events (bone fractures) [ Time Frame: BL, W12, W24, W36, W48, W60, W72, W80, W96 ]
  • Osteoblastic/Osteoclastic activity, bone formation/reabsorption. [ Time Frame: BL, W12, W24, W36, W48, W60, W72, W80, W96 ]

Estimated Enrollment: 65
Arms Assigned Interventions
Experimental: 1
Ibandronate + Lifestyle modifications
Drug: Ibandronate
Ibandronate endovenous 3 mg every 3 months
Behavioral: Lifestyle modifications
Lifestyle modifications: counseling every 3 months
2
Lifestyle modifications
Behavioral: Lifestyle modifications
Lifestyle modifications: counseling every 3 months

Detailed Description:

The lower bone mineral density that has been described in patients with HIV-infection has not meant an increase of long term complications. Nevertheless, it could involve an increase if the associated co-mordibity in the future, taking in care that in general population osteoporosis increases 4 times the pathologic fracture risk. That's why it is necessary to know the real prevalence of osteoporosis in this population of patients so the real dimensions of the problems can be defined.

This project wills to determine the incidence of osteoporosis in our population of HIV-infected patients and to assess the efficacy and security of ibandronate, whose efficacy in post-menopausal women has been already proved. If the quarterly use of endovenous ibandronate obtains equivalent results to those obtained with oral and weekly alendronate in other studies with the same population, its use would be justified because of its posology benefits. The monthly or quarterly administration can improve compliance in patients who are recieving a big quantity of drugs, as HIV infected patients do and who probably have to be treated for life. Moreover, its elimination is renal so there is absence of interactions with antiretroviral drugs what mades of ibandronate a very promising alternative. Finally, there's no risk of digestive intolerance because of its parenteral administration and it has a better posology than oral bifosfonates.

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 18 years old or elder.
  2. Documented HIV-1 infection, with or without antiretroviral treatment.
  3. Presence of WHO osteoporosis criteria, defined as t-score under -2.5 in lumbar, hip and/or trochanter. (DEXA in the last 6 months is needed)
  4. Willing to follow the study protocol.
  5. Informed Consent signature.

Exclusion Criteria:

  1. In women, pregnancy or breastfeeding.
  2. Other possible causes of secondary osteoporosis.
  3. Creatinin over 2.3mg/mL
  4. Glomerular filter less than 50 mL/min (estimated through MDRD)
  5. Alendronate treatment in the last 6 months.
  Contacts and Locations
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): NCT00662077


Locations
Spain
Germans Trias i Pujol Hospital - Lluita Sida Foundation
Badalona, Barcelona, Spain, 08916
Sponsors and Collaborators
Germans Trias i Pujol Hospital
Investigators
Principal Investigator: Eugenia Negredo, MD,PhD Fundacio Lluita Contra la SIDA
  More Information

Responsible Party: LLuita Sida Foundation
ClinicalTrials.gov Identifier: NCT00662077     History of Changes
Other Study ID Numbers: VIH-IBAN
First Submitted: April 17, 2008
First Posted: April 21, 2008
Last Update Posted: August 1, 2008
Last Verified: July 2008

Keywords provided by Germans Trias i Pujol Hospital:
osteoporosis
bifosfonates
ibandronate

Additional relevant MeSH terms:
HIV Infections
Osteoporosis
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Ibandronic acid
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs