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Bisphosphonates

Alendronate for Osteonecrosis in Sickle Cell Disease

Phase 2
Recruiting
Led By Oyebimpe O Adesina, MD, MS
Research Sponsored by University of California, Davis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18-80 years with sickle cell disease (any genotype, confirmed by hemoglobin electrophoresis or high performance liquid chromatography)
Ability to lay on a dual-energy X-ray absorptiometry (DXA) scanner
Must not have
Hospitalizations (for any cause) within 2 weeks of study entry
Adults unable to consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3 months, 6 months
Awards & highlights

Summary

This trial will investigate the effects of taking oral alendronate in adults with sickle cell disease and osteonecrosis.

Who is the study for?
This trial is for adults aged 18-80 with Sickle Cell Disease (SCD) of any genotype, confirmed by specific blood tests. Participants must be able to consent, lay on a DXA scanner for bone density measurements, and women capable of becoming pregnant must have a negative pregnancy test.
What is being tested?
The study is testing the effects of an oral medication called Alendronate Sodium in adults with SCD who are experiencing osteonecrosis, which is bone tissue death due to reduced blood flow.
What are the potential side effects?
Alendronate may cause side effects like stomach pain, heartburn or difficulty swallowing. It can also lead to more serious conditions such as jawbone problems or unusual thigh bone fractures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 80 years old with confirmed sickle cell disease.
Select...
I can lay on a DXA scanner.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have not been hospitalized for any reason in the last 2 weeks.
Select...
I am unable to give consent for myself.
Select...
I am under the age of 18.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3 months, 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 months, 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of Treatment-Emergent Adverse Events as assessed by participant report
Pain assessed by the Adult Sickle Cell Quality of Life Measurement System (ASCQ-Me) Pain Impact questionnaire
Recruitment and retention rates
Secondary study objectives
Serum CTX-1
Serum P1NP

Side effects data

From 2008 Phase 3 trial • 428 Patients • NCT00051558
12%
Back pain
12%
Urinary tract infection
11%
Influenza
9%
Arthralgia
8%
Nausea
8%
Bronchitis
8%
Rheumatoid arthritis
8%
Hypertension
8%
Sinusitis
7%
Headache
7%
Abdominal pain upper
7%
Dyspepsia
7%
Dizziness
7%
Depression
7%
Anaemia
6%
Nasopharyngitis
6%
Pain in extremity
5%
Abdominal pain
5%
Vomiting
4%
Gastritis
3%
Pneumonia
2%
Dyspnoea
2%
Death
1%
Myocardial infarction
1%
Cardiac failure congestive
1%
Cellulitis
1%
Gastroenteritis
1%
Sepsis
1%
Osteoarthritis
1%
Chronic obstructive pulmonary disease
1%
Respiratory arrest
1%
Respiratory failure
1%
Vertebroplasty
1%
Insomnia
1%
Septic shock
1%
Fall
1%
Pulmonary embolism
1%
Bronchopneumonia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Alendronate
Teriparatide

Trial Design

1Treatment groups
Experimental Treatment
Group I: Alendronate groupExperimental Treatment1 Intervention
Single-arm prospective cohort of 24 adult with SCD
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Alendronate Sodium
2002
Completed Phase 3
~960

Find a Location

Who is running the clinical trial?

University of California, DavisLead Sponsor
928 Previous Clinical Trials
4,720,994 Total Patients Enrolled
1 Trials studying Osteonecrosis
53 Patients Enrolled for Osteonecrosis
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,889 Previous Clinical Trials
47,834,183 Total Patients Enrolled
1 Trials studying Osteonecrosis
53 Patients Enrolled for Osteonecrosis
Doris Duke Charitable FoundationOTHER
63 Previous Clinical Trials
264,074 Total Patients Enrolled
1 Trials studying Osteonecrosis
53 Patients Enrolled for Osteonecrosis
~16 spots leftby Dec 2025
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