Ignite Creation Date:
2024-05-05 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00512499
Status:
COMPLETED
Last Update Posted:
2018-01-09
First Post:
2007-08-03
Brief Title:
Strategies to Treat Osteoporosis Following a Fragility Fracture
Sponsor:
Université de Sherbrooke
Organization:
Université de Sherbrooke
Study Overview
Official Title:
Osteoporosis and Peripheral Fractures Treatment and Investigation Multidisciplinary at the chUS
Status:
COMPLETED
Status Verified Date:
2018-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OPTIMUS
Brief Summary:
Osteoporosis is a very frequent and easily treatable disease Rates of treatment of affected patients is very low as few high risk patients initiate treatment and only a minority of those pursue treatment for long enough time to prevent fractures Patients presenting a fragility fracture after 50 years of age are at high risk of osteoporosis and may represent the ideal group of patients in which intervention aimed at improving initiation and persistence on treatment will be most effective
Our first hypothesis is that the availability of a dedicated nurse practitioner to identify patients with fragility fractures among patients presenting at fracture clinics of orthopedic surgeons will increase markedly the rate of identification of osteoporosis
Our second hypothesis is that giving to both the patient and its primary health practitioner PHP the patients clinical biological and radiological data along with individualized care suggestions will yield significantly better results than giving to the patient and its PHP generic information on osteoporosis risk investigation and treatment
Our first hypothesis is that the availability of a dedicated nurse practitioner to identify patients with fragility fractures among patients presenting at fracture clinics of orthopedic surgeons will increase markedly the rate of identification of osteoporosis
Our second hypothesis is that giving to both the patient and its primary health practitioner PHP the patients clinical biological and radiological data along with individualized care suggestions will yield significantly better results than giving to the patient and its PHP generic information on osteoporosis risk investigation and treatment
Detailed Description:
3- The OPTIMUS INTERVENTIONS
31 PROGRAM GOALS and OBJECTIVES
The OPTIMUS program is a health intervention whose aim is to increase the rate of long-term treatment of osteoporosis in patients with incident fragility fractures by addressing both initiation of treatment and persistence on treatment Participation to the program will be voluntary
Specifically the goals of OPTIMUS are
1 To increase the rate of initiation of treatment of osteoporosis following a fragility fracture in patients presenting to the CHUS This rate is currently of about 30 in the Province of Quebec according to the Recognizing Osteoporosis and its Consequences in Quebec ROCQ survey
We hope to demonstrate that a coordinated approach combining successful identification of patients with fragility fractures evaluated at the CHUS quality information to the patients and to family physicians rapid and appropriate management and initiation of treatment see below of these patients by general practitioners will lead to appropriate levels of treatment of osteoporosis after an episode of fracture Our objective is to initiate treatment within 8 months after fracture in at least 50 of such patients who accept to participate with Minimal Intervention 75 with Intensive Intervention and 90 with Immediate treatment The specifics of each Intervention are detailed below
2 Improve long-term adherence to treatment of osteoporosis following initiation of treatment after a fragility fracture The current rate of persistence is 30-50 at 1 year most loss of persistence occurring during the first months
Initiating treatment of osteoporosis is important However long-term adherence to treatment of osteoporosis is very poor with most discontinuation or erratic intake of medication observed during the first few months Our objective is to maintain observance ie intake of at least 80 of the doses of drugs according to patient questionnaires and to delivery of drugs by pharmacists at one year in at least 80 of the patients who have initiated treatment To that end we will also evaluate whether disclosure of the results of measurements of blood markers of bone metabolism will influence patient adherence to treatment over time The correlation of these measurements with results of phone follow up interviews and drug delivery by pharmacists as indicators of adherence will also be determined
Our objectives with the Intensive and Immediate treatment Interventions imply that 60 of patients with a fragility fracture would be treated for at least 16 months ie 80 of the 75 of patients who have initiated a treatment will adhere long-term After 16 months of treatment the rate of loss of adherence is likely to be lower but information is lacking on that subject We will partially address this question by following patients up to 2 years Longer rates of adherence need to be ascertained but this represents an objective that is not part of the current proposal
Why setting these objectives at 60 of long-term adherence to treatment
Our objective to treat 60 of the patients may appear quite low However it is significantly higher than the appalling 20-30 rate of initiation of treatment currently seen in the province of Quebec and in Canada in general combined with the 30-50 long-term adherence observed in practice translating currently into 5-20 of patients taking appropriate long-term treatment for osteoporosis If we are successful the rate of treatment will be increased by 3 to 10 times
On the contrary our objective to treat 60 of the patients may appear unrealistic To attain this goal we have to include all health practitioners involved in patients care eg family physician orthopedist pharmacist and the patients themselves as well as testing additional safety nets to ensure adherence including patients recall by the nurse coordinator estimating the impact of adding the results of serum markers of bone metabolism and allowing problematic patients ie patients with hip fracture those without family physicians those with complex medical situations and those who do not adhere despite all other measures the possibility to obtain a consultation with a bone specialist
Effect on fracture rates If our objective to treat 60 of the patients is attained it is likely to translate into a significant reduction of close to 50 of vertebral fractures a decrease of 80-90 of the risk of recurrent vertebral fracture by bisphosphonates in 60 of the population and of close to 30 of non-vertebral fractures including the hip reduction of 50 of the risk by bisphosphonate use in 60 of the population These fractures are associated with morbidity chronic pain invalidity and increased mortality and contribute to increase the costs to the public Health Care System hospitalization surgery rehabilitation short- mid- and long-term care in nursing homes needed However this impact on fractures will only become evaluable through access to Quebecs Health Insurance Agency RAMQ databases through the regional Health Agency by comparing the rate of new fracture for patients compliant to the intervention relative to the patients who will refuse to give their informed consent to be included into the intervention estimated to 10-15 of the patients with fractures and to the patients who will not be compliant estimated to 40 of the patients who will give their consent to participate In addition this effect on fracture rates will only become significant after a longer period 3-5 years of observation
31 PROGRAM GOALS and OBJECTIVES
The OPTIMUS program is a health intervention whose aim is to increase the rate of long-term treatment of osteoporosis in patients with incident fragility fractures by addressing both initiation of treatment and persistence on treatment Participation to the program will be voluntary
Specifically the goals of OPTIMUS are
1 To increase the rate of initiation of treatment of osteoporosis following a fragility fracture in patients presenting to the CHUS This rate is currently of about 30 in the Province of Quebec according to the Recognizing Osteoporosis and its Consequences in Quebec ROCQ survey
We hope to demonstrate that a coordinated approach combining successful identification of patients with fragility fractures evaluated at the CHUS quality information to the patients and to family physicians rapid and appropriate management and initiation of treatment see below of these patients by general practitioners will lead to appropriate levels of treatment of osteoporosis after an episode of fracture Our objective is to initiate treatment within 8 months after fracture in at least 50 of such patients who accept to participate with Minimal Intervention 75 with Intensive Intervention and 90 with Immediate treatment The specifics of each Intervention are detailed below
2 Improve long-term adherence to treatment of osteoporosis following initiation of treatment after a fragility fracture The current rate of persistence is 30-50 at 1 year most loss of persistence occurring during the first months
Initiating treatment of osteoporosis is important However long-term adherence to treatment of osteoporosis is very poor with most discontinuation or erratic intake of medication observed during the first few months Our objective is to maintain observance ie intake of at least 80 of the doses of drugs according to patient questionnaires and to delivery of drugs by pharmacists at one year in at least 80 of the patients who have initiated treatment To that end we will also evaluate whether disclosure of the results of measurements of blood markers of bone metabolism will influence patient adherence to treatment over time The correlation of these measurements with results of phone follow up interviews and drug delivery by pharmacists as indicators of adherence will also be determined
Our objectives with the Intensive and Immediate treatment Interventions imply that 60 of patients with a fragility fracture would be treated for at least 16 months ie 80 of the 75 of patients who have initiated a treatment will adhere long-term After 16 months of treatment the rate of loss of adherence is likely to be lower but information is lacking on that subject We will partially address this question by following patients up to 2 years Longer rates of adherence need to be ascertained but this represents an objective that is not part of the current proposal
Why setting these objectives at 60 of long-term adherence to treatment
Our objective to treat 60 of the patients may appear quite low However it is significantly higher than the appalling 20-30 rate of initiation of treatment currently seen in the province of Quebec and in Canada in general combined with the 30-50 long-term adherence observed in practice translating currently into 5-20 of patients taking appropriate long-term treatment for osteoporosis If we are successful the rate of treatment will be increased by 3 to 10 times
On the contrary our objective to treat 60 of the patients may appear unrealistic To attain this goal we have to include all health practitioners involved in patients care eg family physician orthopedist pharmacist and the patients themselves as well as testing additional safety nets to ensure adherence including patients recall by the nurse coordinator estimating the impact of adding the results of serum markers of bone metabolism and allowing problematic patients ie patients with hip fracture those without family physicians those with complex medical situations and those who do not adhere despite all other measures the possibility to obtain a consultation with a bone specialist
Effect on fracture rates If our objective to treat 60 of the patients is attained it is likely to translate into a significant reduction of close to 50 of vertebral fractures a decrease of 80-90 of the risk of recurrent vertebral fracture by bisphosphonates in 60 of the population and of close to 30 of non-vertebral fractures including the hip reduction of 50 of the risk by bisphosphonate use in 60 of the population These fractures are associated with morbidity chronic pain invalidity and increased mortality and contribute to increase the costs to the public Health Care System hospitalization surgery rehabilitation short- mid- and long-term care in nursing homes needed However this impact on fractures will only become evaluable through access to Quebecs Health Insurance Agency RAMQ databases through the regional Health Agency by comparing the rate of new fracture for patients compliant to the intervention relative to the patients who will refuse to give their informed consent to be included into the intervention estimated to 10-15 of the patients with fractures and to the patients who will not be compliant estimated to 40 of the patients who will give their consent to participate In addition this effect on fracture rates will only become significant after a longer period 3-5 years of observation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None