Osteoporosis
Conditions
Brief summary
The purpose of this study is to evaluate the long-term effectiveness, safety, and tolerability of FORTEO in a larger, more diverse real world population than studied in clinical trials
Detailed description
Subjects will be followed through a course of FORTEO therapy for up to 24 months and for an additional 24 months after FORTEO treatment is stopped. Subjects may participate in this study for up to 48 months. All aspects of patient care, including diagnostic and therapeutic interventions, will be chosen and conducted at the discretion of the participating study physician according to their clinical judgment and the local standard of medical care.
Interventions
DRUGFORTEO
prescribed in accordance with usual clinical practice for up to 24 months
Sponsors
Eli Lilly and Company
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Men and women who are judged by the study physician to be suitable for FORTEO therapy. The FORTEO product labeling specifies those individuals diagnosed with osteoporosis who are considered to be at high risk for fracture
Exclusion criteria
* Subjects who have an increased baseline risk for osteosarcoma. These include Paget's disease of bone, pediatric populations and young adult patients with open epiphyses, prior external beam or implant radiation therapy involving the skeleton * Subjects who have administered FORTEO or PTH therapy for more than two weeks directly before study entry * Subjects who have completed a course of FORTEO or PTH therapy of at least 18 months duration before study entry
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Non-Vertebral Fragility Fractures | up to 24 months | Non-vertebral fragility fracture is defined as low trauma fracture, such as a fall from standing height. It is binary outcome (Yes/No). Percentage of participants = number of participants with new Non-Vertebral Fragility Fracture/ number of participants at risk \* 100. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Change From Baseline in Back Pain Score by Visual Analog Scale (VAS) at 24 Month Endpoint | Baseline, Month 24 | Visual analog pain scale is a measurement instrument to measure the level of pain. Scores range from 0 to 100. Higher score indicates greater pain. Mean percentage change is (Pain score at baseline visit - Pain score at Month 24)/Pain score at baseline visit\*100%. |
| Percentage Change From Baseline in Pain Score by Visual Analog Scale (VAS) at 24 Month Endpoint | Baseline, Month 24 | Visual analog pain scale is a measurement instrument to measure the level of pain. Scores range from 0 to 100. Higher score indicates greater pain. Mean percentage change is (Pain score at baseline visit - Pain score at Month 24)/Pain score at baseline visit\*100%. |
| Treatment Adherence | up to 24 months | Treatment adherence is the duration of time participants were on Forteo therapy during the 24-month treatment phase of the study. |
| Percentage of Participants With Clinical Vertebral Fractures | up to 24 months | Clinical vertebral fracture was defined as a fracture that caused pain and/or discomfort, came to medical attention, and was confirmed by the investigator. Vertebral fracture sites included thoracic vertebra number 4 (T4) through lumbar spine vertebra number 4 (L4). Vertebral fracture is binary outcome (Yes/No). Percentage of participants= number of participants with new vertebral fracture/ number of participants at risk \* 100. |
| Percentage Change From Baseline in Bone Mineral Content (BMC) at Month 24 Endpoint | Baseline, up to month 24 | BMC is an estimate of the amount of mineral (such as calcium) in the bone. |
| Percentage Change From Baseline in Bone Area at Month 24 Endpoint | Baseline, up to month 24 | Bone area is a defined region of interest of bone. |
| Physician Criteria for Initiating FORTEO Therapy | Baseline | Study investigators were provided a questionnaire that was populated with specific criteria they could choose from when they initiated Forteo therapy for their patients. They could have chosen more than one criteria, thus participants could have been counted multiple times. As this was actually a baseline characteristic rather than an outcome measure, data are presented in the baseline characteristic table rather than here. |
| Percentage Change From Baseline in Bone Mineral Density (BMD) at Month 24 Endpoint | Baseline, up to month 24 | A BMD test measures the amount of mineral (such as calcium) in a defined area of bone, grams per square centimeter (g/cm²). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| FORTEO (Teriparatide)-Treated FORTEO: prescribed in accordance with usual clinical practice for up to 24 months | 3,720 |
| Total | 3,720 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Clinically significant abnormal lab | 5 |
| Overall Study | Death | 134 |
| Overall Study | Didn't take study drug | 82 |
| Overall Study | Lost to Follow-up | 676 |
| Overall Study | Other | 173 |
| Overall Study | Physician Decision | 169 |
| Overall Study | Serious adverse event | 26 |
| Overall Study | Sponsor decision | 46 |
| Overall Study | Withdrawal by Subject | 739 |
Baseline characteristics
| Characteristic | FORTEO (Teriparatide)-Treated |
|---|---|
| Age Continuous | 67.96 years STANDARD_DEVIATION 11.72 |
| Physician Criteria for Initiating FORTEO Therapy Absence of prior authorization criteria | 193 participants |
| Physician Criteria for Initiating FORTEO Therapy Adequate insurance coverage | 925 participants |
| Physician Criteria for Initiating FORTEO Therapy Height loss | 697 participants |
| Physician Criteria for Initiating FORTEO Therapy Inadequate response to previous therapy | 2261 participants |
| Physician Criteria for Initiating FORTEO Therapy Intolerance to previous osteoporosis therapy | 891 participants |
| Physician Criteria for Initiating FORTEO Therapy Multiple fracture risk factors - per investigator | 3395 participants |
| Physician Criteria for Initiating FORTEO Therapy New osteoporotic fracture | 848 participants |
| Physician Criteria for Initiating FORTEO Therapy Participant met Forteo threshold -per investigator | 2215 participants |
| Physician Criteria for Initiating FORTEO Therapy Participant request | 247 participants |
| Race/Ethnicity, Customized African | 57 participants |
| Race/Ethnicity, Customized Asian | 11 participants |
| Race/Ethnicity, Customized Caucasian | 3282 participants |
| Race/Ethnicity, Customized East Asian | 29 participants |
| Race/Ethnicity, Customized Hispanic | 321 participants |
| Race/Ethnicity, Customized Other | 18 participants |
| Race/Ethnicity, Customized Unknown | 2 participants |
| Region of Enrollment United States | 3720 participants |
| Sex/Gender, Customized Female | 3350 participants |
| Sex/Gender, Customized Male | 369 participants |
| Sex/Gender, Customized Unknown | 1 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 432 / 4,085 |
Outcome results
Primary
Percentage of Participants With Non-Vertebral Fragility Fractures
Non-vertebral fragility fracture is defined as low trauma fracture, such as a fall from standing height. It is binary outcome (Yes/No). Percentage of participants = number of participants with new Non-Vertebral Fragility Fracture/ number of participants at risk \* 100.
Time frame: up to 24 months
Population: Participants who received at least one dose of study drug and had non-missing start/stop date, and did not discontinue study drug more than 3 consecutive months at onetime during treatment phase.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FORTEO (Teriparatide)-Treated | Percentage of Participants With Non-Vertebral Fragility Fractures | 0 to 6 months (n=3720) | 1.42 Percentage of participants |
| FORTEO (Teriparatide)-Treated | Percentage of Participants With Non-Vertebral Fragility Fractures | 6 to 12 months (n=2970) | 0.91 Percentage of participants |
| FORTEO (Teriparatide)-Treated | Percentage of Participants With Non-Vertebral Fragility Fractures | 12 to 18 months (n=2570) | 0.70 Percentage of participants |
| FORTEO (Teriparatide)-Treated | Percentage of Participants With Non-Vertebral Fragility Fractures | 18 to 24 months (n=2225) | 0.81 Percentage of participants |
p-value: 0.0177One-sample binomial proportion test
p-value: 0.0019One-sample binomial proportion test
p-value: 0.0143One-sample binomial proportion test
Secondary
Percentage Change From Baseline in Back Pain Score by Visual Analog Scale (VAS) at 24 Month Endpoint
Visual analog pain scale is a measurement instrument to measure the level of pain. Scores range from 0 to 100. Higher score indicates greater pain. Mean percentage change is (Pain score at baseline visit - Pain score at Month 24)/Pain score at baseline visit\*100%.
Time frame: Baseline, Month 24
Population: Participants with at least a VAS score of 40 at baseline and at least one post-baseline measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FORTEO (Teriparatide)-Treated | Percentage Change From Baseline in Back Pain Score by Visual Analog Scale (VAS) at 24 Month Endpoint | -36.2 percentage change of pain score | Standard Error 2.8 |
p-value: <0.001t-test, 2 sided
Secondary
Percentage Change From Baseline in Bone Area at Month 24 Endpoint
Bone area is a defined region of interest of bone.
Time frame: Baseline, up to month 24
Population: Participants who received at least one dose of study drug and had non-missing start/stop date, and did not discontinue study drug more than 3 consecutive months at onetime during treatment phase. At least one post-baseline measurement within 24 month, last observation carried forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FORTEO (Teriparatide)-Treated | Percentage Change From Baseline in Bone Area at Month 24 Endpoint | Femoral Neck | 2.231 percent change of centimeter square | Standard Error 1.336 |
| FORTEO (Teriparatide)-Treated | Percentage Change From Baseline in Bone Area at Month 24 Endpoint | Forearm | 4.680 percent change of centimeter square | Standard Error 4.705 |
| FORTEO (Teriparatide)-Treated | Percentage Change From Baseline in Bone Area at Month 24 Endpoint | Inter-Trochanter | 1.828 percent change of centimeter square | Standard Error 0.661 |
| FORTEO (Teriparatide)-Treated | Percentage Change From Baseline in Bone Area at Month 24 Endpoint | L1-L4 | 3.907 percent change of centimeter square | Standard Error 1.242 |
| FORTEO (Teriparatide)-Treated | Percentage Change From Baseline in Bone Area at Month 24 Endpoint | Total Hip | 2.648 percent change of centimeter square | Standard Error 1.453 |
| FORTEO (Teriparatide)-Treated | Percentage Change From Baseline in Bone Area at Month 24 Endpoint | Trochanter | 3.395 percent change of centimeter square | Standard Error 2.375 |
| FORTEO (Teriparatide)-Treated | Percentage Change From Baseline in Bone Area at Month 24 Endpoint | Wards Triangle | 1.826 percent change of centimeter square | Standard Error 1.171 |
Secondary
Percentage Change From Baseline in Bone Mineral Content (BMC) at Month 24 Endpoint
BMC is an estimate of the amount of mineral (such as calcium) in the bone.
Time frame: Baseline, up to month 24
Population: Participants who received at least one dose of study drug and had non-missing start/stop date, and did not discontinue study drug more than 3 consecutive months at onetime during treatment phase. At least one post-baseline measurement within 24 month, last observation carried forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FORTEO (Teriparatide)-Treated | Percentage Change From Baseline in Bone Mineral Content (BMC) at Month 24 Endpoint | Femoral Neck | 4.187 percentage (%) change of grams (g) | Standard Error 1.707 |
| FORTEO (Teriparatide)-Treated | Percentage Change From Baseline in Bone Mineral Content (BMC) at Month 24 Endpoint | Forearm | 7.243 percentage (%) change of grams (g) | Standard Error 7.995 |
| FORTEO (Teriparatide)-Treated | Percentage Change From Baseline in Bone Mineral Content (BMC) at Month 24 Endpoint | Inter-Trochanter | 5.716 percentage (%) change of grams (g) | Standard Error 2.684 |
| FORTEO (Teriparatide)-Treated | Percentage Change From Baseline in Bone Mineral Content (BMC) at Month 24 Endpoint | L1-L4 | 20.774 percentage (%) change of grams (g) | Standard Error 11.226 |
| FORTEO (Teriparatide)-Treated | Percentage Change From Baseline in Bone Mineral Content (BMC) at Month 24 Endpoint | Total Hip | 8.303 percentage (%) change of grams (g) | Standard Error 6.866 |
| FORTEO (Teriparatide)-Treated | Percentage Change From Baseline in Bone Mineral Content (BMC) at Month 24 Endpoint | Trochanter | 4.968 percentage (%) change of grams (g) | Standard Error 2.899 |
| FORTEO (Teriparatide)-Treated | Percentage Change From Baseline in Bone Mineral Content (BMC) at Month 24 Endpoint | Wards Triangle | 50.996 percentage (%) change of grams (g) | Standard Error 30.54 |
Secondary
Percentage Change From Baseline in Bone Mineral Density (BMD) at Month 24 Endpoint
A BMD test measures the amount of mineral (such as calcium) in a defined area of bone, grams per square centimeter (g/cm²).
Time frame: Baseline, up to month 24
Population: Participants who received at least one dose of study drug and had non-missing start/stop date, and did not discontinue study drug more than 3 consecutive months at onetime during treatment phase. At least one post-baseline measurement within 24 month, last observation carried forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FORTEO (Teriparatide)-Treated | Percentage Change From Baseline in Bone Mineral Density (BMD) at Month 24 Endpoint | Femoral Neck | 2.569 percentage (%) change of BMD | Standard Error 0.944 |
| FORTEO (Teriparatide)-Treated | Percentage Change From Baseline in Bone Mineral Density (BMD) at Month 24 Endpoint | Forearm | 0.626 percentage (%) change of BMD | Standard Error 1.421 |
| FORTEO (Teriparatide)-Treated | Percentage Change From Baseline in Bone Mineral Density (BMD) at Month 24 Endpoint | Inter-Trochanter | 1.532 percentage (%) change of BMD | Standard Error 0.413 |
| FORTEO (Teriparatide)-Treated | Percentage Change From Baseline in Bone Mineral Density (BMD) at Month 24 Endpoint | Lumbar spine vertebrae numbered 1 through 4(L1-L4) | 6.419 percentage (%) change of BMD | Standard Error 0.334 |
| FORTEO (Teriparatide)-Treated | Percentage Change From Baseline in Bone Mineral Density (BMD) at Month 24 Endpoint | Total Hip | 3.766 percentage (%) change of BMD | Standard Error 1.721 |
| FORTEO (Teriparatide)-Treated | Percentage Change From Baseline in Bone Mineral Density (BMD) at Month 24 Endpoint | Trochanter | 2.604 percentage (%) change of BMD | Standard Error 1.186 |
| FORTEO (Teriparatide)-Treated | Percentage Change From Baseline in Bone Mineral Density (BMD) at Month 24 Endpoint | Wards Triangle | 3.394 percentage (%) change of BMD | Standard Error 0.761 |
Secondary
Percentage Change From Baseline in Pain Score by Visual Analog Scale (VAS) at 24 Month Endpoint
Visual analog pain scale is a measurement instrument to measure the level of pain. Scores range from 0 to 100. Higher score indicates greater pain. Mean percentage change is (Pain score at baseline visit - Pain score at Month 24)/Pain score at baseline visit\*100%.
Time frame: Baseline, Month 24
Population: Participants with at least a VAS score of 40 at baseline and at least one post-baseline measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FORTEO (Teriparatide)-Treated | Percentage Change From Baseline in Pain Score by Visual Analog Scale (VAS) at 24 Month Endpoint | -24.9 percentage change of pain score | Standard Error 2.2 |
p-value: <0.001t-test, 2 sided
Secondary
Percentage of Participants With Clinical Vertebral Fractures
Clinical vertebral fracture was defined as a fracture that caused pain and/or discomfort, came to medical attention, and was confirmed by the investigator. Vertebral fracture sites included thoracic vertebra number 4 (T4) through lumbar spine vertebra number 4 (L4). Vertebral fracture is binary outcome (Yes/No). Percentage of participants= number of participants with new vertebral fracture/ number of participants at risk \* 100.
Time frame: up to 24 months
Population: Participants who received at least one dose of study drug and had non-missing start/stop date, and did not discontinue study drug more than 3 consecutive months at onetime during treatment phase.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FORTEO (Teriparatide)-Treated | Percentage of Participants With Clinical Vertebral Fractures | 0 to 6 months (n=3720) | 0.67 Percentage of participants |
| FORTEO (Teriparatide)-Treated | Percentage of Participants With Clinical Vertebral Fractures | 6 to 12 months (n=2996) | 0.40 Percentage of participants |
| FORTEO (Teriparatide)-Treated | Percentage of Participants With Clinical Vertebral Fractures | 12 to 18 months (n=2606) | 0.35 Percentage of participants |
| FORTEO (Teriparatide)-Treated | Percentage of Participants With Clinical Vertebral Fractures | 18 to 24 months (n=2266) | 0.35 Percentage of participants |
p-value: 0.0689One-sample binomial proportion test
p-value: 0.0412One-sample binomial proportion test
p-value: 0.0631One-sample binomial proportion test
Secondary
Physician Criteria for Initiating FORTEO Therapy
Study investigators were provided a questionnaire that was populated with specific criteria they could choose from when they initiated Forteo therapy for their patients. They could have chosen more than one criteria, thus participants could have been counted multiple times. As this was actually a baseline characteristic rather than an outcome measure, data are presented in the baseline characteristic table rather than here.
Time frame: Baseline
Population: Participants are those who took at least one dose of study drug and had reasons documented to initiate Forteo therapy. This is a baseline characteristic; therefore data are presented in the section of Baseline Characteristics.
Secondary
Treatment Adherence
Treatment adherence is the duration of time participants were on Forteo therapy during the 24-month treatment phase of the study.
Time frame: up to 24 months
Population: Participants who received at least one dose of study drug and had non-missing start/stop date, and did not discontinue study drug more than 3 consecutive months at onetime during treatment phase.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FORTEO (Teriparatide)-Treated | Treatment Adherence | 0 to 6 months (n=701) | 72.5 days | Standard Deviation 54.5 |
| FORTEO (Teriparatide)-Treated | Treatment Adherence | 6 to 12 months (n=382) | 272.5 days | Standard Deviation 57.7 |
| FORTEO (Teriparatide)-Treated | Treatment Adherence | 12 to 18 months (n=338) | 450.7 days | Standard Deviation 59 |
| FORTEO (Teriparatide)-Treated | Treatment Adherence | 18 to 24 months (n=2299) | 743.7 days | Standard Deviation 115.7 |